Trial Outcomes & Findings for Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) (NCT NCT00509795)

Last Updated: 2012-12-28

Results Overview

Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1217 participants

Primary outcome timeframe

Baseline and at week 52

Results posted on

2012-12-28

Participant Flow

The study was conducted at 164 sites in the United States and Canada. Recruitment period: 02 Aug 2007 to 15 Sep 2009.

2063 patients were screened, 1217 randomized, and 1215 included in the Safety Analysis Set (SAF). The Full Analysis Set (FAS) included 1210 patients with at least 1 post-baseline assessment. The Per Protocol Set (PPS) included 1089 patients who received ≥ 9 doses of study drug and attended ≥ 9 scheduled visits during the first year.

Participant milestones

Participant milestones
Measure	Ranibizumab 0.5mg Q4 Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.
Overall Study STARTED	306	304	304	303
Overall Study Patients Received Treatment (SAF)	304	304	304	303
Overall Study Full Analysis Set (FAS) Population	304	304	301	301
Overall Study Per Protocol Set (PPS) Population	269	285	270	265
Overall Study COMPLETED	284	293	277	276
Overall Study NOT COMPLETED	22	11	27	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranibizumab 0.5mg Q4 Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.
Overall Study Adverse Event	4	3	5	4
Overall Study Death	3	1	2	7
Overall Study Lack of Efficacy	0	0	2	2
Overall Study Lost to Follow-up	1	2	4	4
Overall Study OTHER	1	0	4	1
Overall Study Protocol Violation	3	0	3	1
Overall Study Withdrawal by Subject	10	5	7	8

Baseline Characteristics

Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranibizumab 0.5mg Q4 n=304 Participants Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 n=304 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 n=304 Participants Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 n=303 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.	Total n=1215 Participants Total of all reporting groups
Age Continuous	78.2 years STANDARD_DEVIATION 7.59 • n=5 Participants	77.7 years STANDARD_DEVIATION 7.93 • n=7 Participants	78.3 years STANDARD_DEVIATION 8.10 • n=5 Participants	77.9 years STANDARD_DEVIATION 8.39 • n=4 Participants	78.0 years STANDARD_DEVIATION 8.00 • n=21 Participants
Sex: Female, Male Female	172 Participants n=5 Participants	194 Participants n=7 Participants	169 Participants n=5 Participants	179 Participants n=4 Participants	714 Participants n=21 Participants
Sex: Female, Male Male	132 Participants n=5 Participants	110 Participants n=7 Participants	135 Participants n=5 Participants	124 Participants n=4 Participants	501 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants 0 • n=5 Participants	11 Participants 0 • n=7 Participants	11 Participants 0 • n=5 Participants	12 Participants 0 • n=4 Participants	41 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	297 Participants n=5 Participants	293 Participants n=7 Participants	293 Participants n=5 Participants	291 Participants n=4 Participants	1174 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants 0 • n=5 Participants	0 Participants 0 • n=7 Participants	2 Participants 0 • n=5 Participants	1 Participants 0 • n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants 0 • n=5 Participants	3 Participants 0 • n=7 Participants	5 Participants 0 • n=5 Participants	4 Participants 0 • n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants 0 • n=5 Participants	0 Participants 0 • n=7 Participants	0 Participants 0 • n=5 Participants	1 Participants 0 • n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants 0 • n=5 Participants	1 Participants 0 • n=7 Participants	0 Participants 0 • n=5 Participants	1 Participants 0 • n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	296 Participants 0 • n=5 Participants	295 Participants 0 • n=7 Participants	294 Participants 0 • n=5 Participants	289 Participants 0 • n=4 Participants	1174 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants 0 • n=5 Participants	0 Participants 0 • n=7 Participants	0 Participants 0 • n=5 Participants	1 Participants 0 • n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants 0 • n=5 Participants	5 Participants 0 • n=7 Participants	3 Participants 0 • n=5 Participants	6 Participants 0 • n=4 Participants	18 Participants n=21 Participants
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score	71.7 scores on a scale STANDARD_DEVIATION 17.29 • n=5 Participants	70.4 scores on a scale STANDARD_DEVIATION 16.60 • n=7 Participants	71.1 scores on a scale STANDARD_DEVIATION 17.72 • n=5 Participants	69.5 scores on a scale STANDARD_DEVIATION 16.82 • n=4 Participants	70.7 scores on a scale STANDARD_DEVIATION 17.11 • n=21 Participants
Baseline Area of Choroidal Neovascularization (CNV)	6.52 mm^2 STANDARD_DEVIATION 5.245 • n=5 Participants	6.59 mm^2 STANDARD_DEVIATION 5.052 • n=7 Participants	6.49 mm^2 STANDARD_DEVIATION 4.437 • n=5 Participants	6.56 mm^2 STANDARD_DEVIATION 5.129 • n=4 Participants	6.54 mm^2 STANDARD_DEVIATION 4.968 • n=21 Participants
Baseline Lesion Type Occult	115 patients 0 • n=5 Participants	110 patients 0 • n=7 Participants	123 patients 0 • n=5 Participants	118 patients 0 • n=4 Participants	466 patients n=21 Participants
Baseline Lesion Type Minimally Classic	101 patients 0 • n=5 Participants	105 patients 0 • n=7 Participants	97 patients 0 • n=5 Participants	112 patients 0 • n=4 Participants	415 patients n=21 Participants
Baseline Lesion Type Predominantly Classic	82 patients 0 • n=5 Participants	87 patients 0 • n=7 Participants	82 patients 0 • n=5 Participants	71 patients 0 • n=4 Participants	322 patients n=21 Participants
Baseline Lesion Type Missing	6 patients 0 • n=5 Participants	2 patients 0 • n=7 Participants	2 patients 0 • n=5 Participants	2 patients 0 • n=4 Participants	12 patients n=21 Participants
Baseline Total Lesion Size	6.99 mm^2 STANDARD_DEVIATION 5.491 • n=5 Participants	6.98 mm^2 STANDARD_DEVIATION 5.388 • n=7 Participants	6.96 mm^2 STANDARD_DEVIATION 4.711 • n=5 Participants	6.88 mm^2 STANDARD_DEVIATION 5.214 • n=4 Participants	6.95 mm^2 STANDARD_DEVIATION 5.202 • n=21 Participants
Baseline Best Corrected Visual Acuity (BCVA)	54.0 letters read STANDARD_DEVIATION 13.43 • n=5 Participants	55.2 letters read STANDARD_DEVIATION 13.15 • n=7 Participants	55.5 letters read STANDARD_DEVIATION 13.12 • n=5 Participants	55.7 letters read STANDARD_DEVIATION 12.84 • n=4 Participants	55.1 letters read STANDARD_DEVIATION 13.14 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline and at week 52

Population: PPS population used for analysis.

Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5mg Q4 n=269 Participants Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 n=285 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 n=270 Participants Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 n=265 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.	Total n=1089 Participants
Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)	94.4 percentage of patients 0	95.1 percentage of patients 0	95.9 percentage of patients 0	95.1 percentage of patients 0	95.1 percentage of patients 0

SECONDARY outcome

Timeframe: Baseline and at week 52

Population: FAS population used for analysis.

Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5mg Q4 n=304 Participants Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 n=304 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 n=301 Participants Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 n=301 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.	Total n=1210 Participants
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF	8.1 letters read Standard Deviation 15.25	10.9 letters read Standard Deviation 13.77	6.9 letters read Standard Deviation 13.41	7.9 letters read Standard Deviation 15.00	8.5 letters read Standard Deviation 14.44

SECONDARY outcome

Timeframe: Baseline and at week 52

Population: FAS population used for analysis.

Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5mg Q4 n=304 Participants Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 n=304 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 n=301 Participants Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 n=301 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.	Total n=1210 Participants
Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.	30.9 percentage of patients 0	37.5 percentage of patients 0	24.9 percentage of patients 0	30.6 percentage of patients 0	31.1 percentage of patients 0

SECONDARY outcome

Timeframe: Baseline and at Week 52

Population: FAS population used for analysis.

The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5mg Q4 n=304 Participants Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 n=304 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 n=301 Participants Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 n=301 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.	Total n=1210 Participants
Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF	4.9 scores on a scale Standard Deviation 14.01	6.7 scores on a scale Standard Deviation 13.50	4.5 scores on a scale Standard Deviation 11.87	5.1 scores on a scale Standard Deviation 14.74	5.3 scores on a scale Standard Deviation 13.59

SECONDARY outcome

Timeframe: Baseline and at week 52

Population: FAS population used for analysis.

CNV area values measured in square millimeters (mm\^2); lower values represent better outcomes.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5mg Q4 n=304 Participants Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 n=304 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 n=301 Participants Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 n=301 Participants Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.	Total n=1210 Participants
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)	-4.2 mm^2 Standard Deviation 5.59	-4.6 mm^2 Standard Deviation 5.47	-3.5 mm^2 Standard Deviation 5.27	-3.4 mm^2 Standard Deviation 6.02	-3.9 mm^2 Standard Deviation 5.61

Adverse Events

Ranibizumab 0.5mg Q4

Serious events: 94 serious events

Other events: 261 other events

Deaths: 0 deaths

IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4

Serious events: 70 serious events

Other events: 254 other events

Deaths: 0 deaths

IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4

Serious events: 88 serious events

Other events: 262 other events

Deaths: 0 deaths

IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8

Serious events: 90 serious events

Other events: 258 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After completion of the trial, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review; provided that the sponsor can remove confidential or proprietary information from such communications. The sponsor cannot require other changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Ranibizumab 0.5mg Q4 n=304 participants at risk Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of ranibizumab (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 n=304 participants at risk Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 n=304 participants at risk Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 n=303 participants at risk Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Blood and lymphatic system disorders ANAEMIA	0.66% 2/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.66% 2/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Blood and lymphatic system disorders COAGULOPATHY	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders ARTHROPATHY	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	1.3% 4/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.99% 3/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders SPONDYLOLISTHESIS	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ATYPICAL FIBROXANTHOMA	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.66% 2/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA RECURRENT	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRAIN NEOPLASM	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.66% 2/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.66% 2/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST Neoplasms benign, malignant and unspecified (incl cysts and polyps) IN SITU	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIOLOALVEOLAR CARCINOMA	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARDIAC MYXOMA	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECURRENT	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM MALIGNANT	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKAEMIA	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.66% 2/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.66% 2/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE II	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO Hepatobiliary disorders	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.33% 1/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	0.00% 0/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.

Other adverse events
Measure	Ranibizumab 0.5mg Q4 n=304 participants at risk Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of ranibizumab (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 n=304 participants at risk Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 n=304 participants at risk Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 n=303 participants at risk Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	2.6% 8/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Musculoskeletal and connective tissue disorders BACK PAIN	3.6% 11/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.3% 13/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	1.6% 5/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.6% 11/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.9% 15/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.6% 17/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Vascular disorders HYPERTENSION	11.5% 35/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	9.9% 30/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	10.5% 32/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	10.9% 33/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Gastrointestinal disorders DIARRHOEA	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	2.6% 8/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.0% 9/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Gastrointestinal disorders NAUSEA	4.9% 15/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.9% 15/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.0% 15/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Ear and labyrinth disorders ATRIOVENTRICULAR BLOCK FIRST DEGREE	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	2.6% 8/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.0% 9/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Infections and infestations BRONCHITIS	7.6% 23/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	6.2% 19/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	7.9% 24/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Infections and infestations NASOPHARYNGITIS	11.8% 36/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	15.1% 46/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	13.5% 41/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	12.9% 39/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Infections and infestations SINUSITIS	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.3% 13/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Infections and infestations UPPER RESPIRATORY TRACT Infections and infestationsION	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	6.2% 19/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	8.6% 26/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Infections and infestations URINARY TRACT Infections and infestationsION	8.6% 26/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	7.2% 22/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	8.2% 25/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	7.6% 23/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Injury, poisoning and procedural complications FALL	6.2% 19/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.3% 13/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.9% 15/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	6.9% 21/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Investigations Blood and lymphatic system disorders GLUCOSE INCREASED	4.3% 13/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.9% 12/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Nervous system disorders HEADACHE	6.9% 21/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.0% 15/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Respiratory, thoracic and mediastinal disorders COUGH	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.3% 13/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.3% 13/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders AGE-RELATED MACULAR DEGENERATION	6.9% 21/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.9% 12/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.0% 15/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders BLEPHARITIS	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders CATARACT	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders CHOROIDAL NEOVASCULARISATION	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.3% 13/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.0% 9/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders CONJUNCTIVAL HAEMORRHAGE	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	6.3% 19/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders MACULAR DEGENERATION	7.2% 22/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	6.9% 21/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders RETINAL HAEMORRHAGE	14.1% 43/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	11.8% 36/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	11.8% 36/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	7.3% 22/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders RETINAL OEDEMA	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	2.6% 8/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.9% 12/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.6% 11/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders VISUAL ACUITY REDUCED	8.9% 27/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	6.6% 20/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	6.3% 19/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders VITREOUS DETACHMENT	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	7.9% 24/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	8.2% 25/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	7.9% 24/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Investigations INTRAOCULAR PRESSURE INCREASED	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	2.6% 8/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.9% 15/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.0% 15/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders DRY Eye disorders	3.9% 12/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders Eye disorders IRRITATION	6.2% 19/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.3% 13/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.9% 15/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders Eye disorders PAIN	11.2% 34/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	12.8% 39/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	11.5% 35/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	10.2% 31/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders Eye disorders PRURITUS	3.6% 11/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	2.0% 6/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders FOREIGN BODY SENSATION IN Eye disordersS	3.0% 9/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.3% 10/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	6.3% 19/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders LACRIMATION INCREASED	3.6% 11/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	3.6% 11/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.9% 15/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.3% 16/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders RETINAL PIGMENT EPITHELIOPATHY	4.6% 14/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.6% 14/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders VISION BLURRED	3.9% 12/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.9% 18/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	5.6% 17/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	4.3% 13/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.
Eye disorders VITREOUS FLOATERS	15.5% 47/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	16.1% 49/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	9.9% 30/304 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.	9.6% 29/303 • AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks. Yr 2 of tx (Wk 52 to Wk 96): Pts evaluated every 4 wks and received IVT injections of study drug (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 wks.