Trial Outcomes & Findings for An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO (NCT NCT00379795)

Last Updated: 2017-05-11

Results Overview

Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye). Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.

Recruitment status

COMPLETED

Study phase

Target enrollment

853 participants

Primary outcome timeframe

36 months

Results posted on

2017-05-11

Participant Flow

This is an open label multicenter extension study for participants who have completed one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823). Cohort 1 includes patients with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).

Participants were classified according to ranibizumab exposure in the previous study and in the extension study. 63 participants (Untreated Group) did not receive study drug in this extension study or in the previous studies and are not included in the safety analyses.

Participant milestones

Participant milestones
Measure	RanibizumabTreated Initial Mono In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.	RanibizumabTreated Initial + PDT In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g	RanibizumabTreated Sham XO In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.	Ranibizumab Treated PDT XO In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.	Ranibizumab Untreated Group In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).
Overall Study STARTED	526	74	116	74	63
Overall Study Received Ranibizumab in Extension Study	377	41	113	55	0
Overall Study COMPLETED	50	23	23	6	14
Overall Study NOT COMPLETED	476	51	93	68	49

Reasons for withdrawal

Reasons for withdrawal
Measure	RanibizumabTreated Initial Mono In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.	RanibizumabTreated Initial + PDT In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g	RanibizumabTreated Sham XO In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.	Ranibizumab Treated PDT XO In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.	Ranibizumab Untreated Group In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).
Overall Study Death	31	8	6	4	7
Overall Study Adverse Event	17	3	3	1	4
Overall Study Lost to Follow-up	8	1	2	1	4
Overall Study Physician Decision	25	0	2	2	2
Overall Study Withdrawal by Subject	94	11	19	7	14
Overall Study Subject non-compliance	7	2	0	0	1
Overall Study Verteporfin photodynamic therapy in eye	3	0	0	1	0
Overall Study Subjects condition mandated intervention	34	9	7	5	7
Overall Study Sponsor's decision	257	17	54	47	10

Baseline Characteristics

An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RanibizumabTreated Initial Mono n=526 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.	RanibizumabTreated Initial + PDT n=74 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.	RanibizumabTreated Sham XO n=116 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.	Ranibizumab Treated PDT XO n=74 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.	Ranibizumab Untreated Group n=63 Participants In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).	Total n=853 Participants Total of all reporting groups
Age, Customized 50 to < 65	29 participants n=93 Participants	5 participants n=4 Participants	5 participants n=27 Participants	8 participants n=483 Participants	4 participants n=36 Participants	51 participants n=10 Participants
Age, Customized 65 to < 75	117 participants n=93 Participants	19 participants n=4 Participants	27 participants n=27 Participants	21 participants n=483 Participants	10 participants n=36 Participants	194 participants n=10 Participants
Age, Customized 75 to < 85	277 participants n=93 Participants	42 participants n=4 Participants	61 participants n=27 Participants	35 participants n=483 Participants	29 participants n=36 Participants	444 participants n=10 Participants
Age, Customized >= 85	103 participants n=93 Participants	8 participants n=4 Participants	23 participants n=27 Participants	10 participants n=483 Participants	20 participants n=36 Participants	164 participants n=10 Participants
Sex: Female, Male Female	304 Participants n=93 Participants	42 Participants n=4 Participants	76 Participants n=27 Participants	41 Participants n=483 Participants	36 Participants n=36 Participants	499 Participants n=10 Participants
Sex: Female, Male Male	222 Participants n=93 Participants	32 Participants n=4 Participants	40 Participants n=27 Participants	33 Participants n=483 Participants	27 Participants n=36 Participants	354 Participants n=10 Participants

PRIMARY outcome

Timeframe: 36 months

Population: All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.

Outcome measures

Outcome measures
Measure	Ranibizumab Treated Initial Mono n=526 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.	Ranibizumab Treated Initial + PDT n=74 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.	Ranibizumab Treated Sham XO n=116 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.	Ranibizumab Treated PDT XO n=74 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
Number of Participants With Ocular Adverse Events Any adverse event in study eye	418 participants	56 participants	96 participants	59 participants
Number of Participants With Ocular Adverse Events Serious adverse events in study eye	46 participants	2 participants	6 participants	2 participants
Number of Participants With Ocular Adverse Events Adverse events led to discontinuation, study eye	7 participants	2 participants	3 participants	2 participants
Number of Participants With Ocular Adverse Events Endophthalmitis in study eye	1 participants	0 participants	0 participants	0 participants
Number of Participants With Ocular Adverse Events Intraocular inflammation in study eye, total	8 participants	2 participants	4 participants	1 participants
Number of Participants With Ocular Adverse Events Serious Intraocular inflammation in study eye	1 participants	0 participants	0 participants	0 participants
Number of Participants With Ocular Adverse Events Any adverse event in fellow eye	304 participants	50 participants	72 participants	47 participants
Number of Participants With Ocular Adverse Events Serious adverse events in fellow eye	22 participants	4 participants	6 participants	3 participants
Number of Participants With Ocular Adverse Events Adverse events led to discontinuation, fellow eye	6 participants	7 participants	4 participants	3 participants
Number of Participants With Ocular Adverse Events Endophthalmitis in fellow eye	0 participants	0 participants	0 participants	0 participants
Number of Participants With Ocular Adverse Events Intraocular inflammation in fellow eye, total	5 participants	0 participants	0 participants	0 participants
Number of Participants With Ocular Adverse Events Serious intraocular inflammation in fellow eye	1 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 36 months

Population: Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.

Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section.

Outcome measures

Outcome measures
Measure	Ranibizumab Treated Initial Mono n=526 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.	Ranibizumab Treated Initial + PDT n=74 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.	Ranibizumab Treated Sham XO n=116 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.	Ranibizumab Treated PDT XO n=74 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
Number of Participants With Non-ocular Adverse Events Any non ocular adverse event	427 participants	61 participants	92 participants	58 participants
Number of Participants With Non-ocular Adverse Events Serious non ocular adverse event	169 participants	21 participants	33 participants	20 participants
Number of Participants With Non-ocular Adverse Events Non ocular adverse events led to discontinuation	27 participants	2 participants	1 participants	0 participants
Number of Participants With Non-ocular Adverse Events Death	31 participants	8 participants	6 participants	4 participants

PRIMARY outcome

Timeframe: Month 12 and 24

Population: Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by "n"

Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.

Outcome measures

Outcome measures
Measure	Ranibizumab Treated Initial Mono n=526 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.	Ranibizumab Treated Initial + PDT n=74 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.	Ranibizumab Treated Sham XO n=116 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.	Ranibizumab Treated PDT XO n=74 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 Month 12 (n=393,55,72,50)	10 participants	0 participants	1 participants	0 participants
Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 Month 24 (n=316,45,78,42)	9 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24

Population: Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".

Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.

Outcome measures

Outcome measures
Measure	Ranibizumab Treated Initial Mono n=600 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.	Ranibizumab Treated Initial + PDT n=190 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.	Ranibizumab Treated Sham XO n=63 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.	Ranibizumab Treated PDT XO n=853 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters Change from Baseline at Month 3 (n=284, 84, 25)	-2.9 letters Standard Deviation 8.9	-2.9 letters Standard Deviation 11.0	0.1 letters Standard Deviation 6.6	-2.7 letters Standard Deviation 9.3
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters Change from Baseline at Month 6 (n=519, 149, 46)	-3.4 letters Standard Deviation 8.8	-1.6 letters Standard Deviation 10.5	0.3 letters Standard Deviation 7.0	-2.8 letters Standard Deviation 9.1
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters Change from Baseline at Month 9 (n=490, 149, 38)	-4.4 letters Standard Deviation 10.8	-1.7 letters Standard Deviation 11.3	-2.2 letters Standard Deviation 7.5	-3.7 letters Standard Deviation 10.8
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters Change from Baseline at Month 12 (n=481, 142, 38)	-5.2 letters Standard Deviation 11.1	-2.3 letters Standard Deviation 11.5	-3.2 letters Standard Deviation 8.0	-4.5 letters Standard Deviation 11.1
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters Change from Baseline at Month 15 (n=447, 138, 31)	-5.6 letters Standard Deviation 10.8	-2.2 letters Standard Deviation 12.4	-3.0 letters Standard Deviation 8.9	-4.7 letters Standard Deviation 11.2
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters Change from Baseline at Month 18 (n=420, 135, 28)	-6.4 letters Standard Deviation 11.9	-2.0 letters Standard Deviation 12.5	-4.4 letters Standard Deviation 9.5	-5.3 letters Standard Deviation 12.1
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters Change from Baseline at Month 21 (n=405, 129, 28)	-7.9 letters Standard Deviation 13.0	-2.1 letters Standard Deviation 13.3	-3.5 letters Standard Deviation 10.8	-6.3 letters Standard Deviation 13.2
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters Change from Baseline at Month 24 (n=388, 127, 27)	-8.1 letters Standard Deviation 13.0	-2.0 letters Standard Deviation 13.5	-2.9 letters Standard Deviation 8.5	-6.4 letters Standard Deviation 13.2

SECONDARY outcome

Timeframe: Extension study baseline, Months 12 and 24

Population: Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".

Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.

Outcome measures

Outcome measures
Measure	Ranibizumab Treated Initial Mono n=600 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.	Ranibizumab Treated Initial + PDT n=190 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.	Ranibizumab Treated Sham XO n=63 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.	Ranibizumab Treated PDT XO n=853 Participants In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters Change from Baseline at Month 12 (n=446,133,35)	-5.4 letters Standard Deviation 11.8	-1.3 letters Standard Deviation 11.8	-3.2 letters Standard Deviation 7.2	-4.4 letters Standard Deviation 11.7
Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters Change from Baseline at Month 24 (n=352,122,25)	-7.5 letters Standard Deviation 12.3	-0.8 letters Standard Deviation 13.0	-3.1 letters Standard Deviation 8.2	-5.7 letters Standard Deviation 12.7

Adverse Events

Ranibizumab Treated Initial Mono

Serious events: 213 serious events

Other events: 491 other events

Deaths: 0 deaths

Ranibizumab Treated Initial + PDT

Serious events: 26 serious events

Other events: 70 other events

Deaths: 0 deaths

Ranibizumab Treated Sham XO

Serious events: 43 serious events

Other events: 110 other events

Deaths: 0 deaths

Ranibizumab Treated PDT XO

Serious events: 24 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Genentech

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place