Trial Outcomes & Findings for Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD (NCT NCT01948830)
NCT ID: NCT01948830
Last Updated: 2017-04-17
Results Overview
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
650 participants
Primary outcome timeframe
Baseline to month 12
Results posted on
2017-04-17
Participant Flow
Patients were randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens. Safety set: One patient was randomized but did not receive at least one study treatment and did not record at least one post-baseline safety assessment
Participant milestones
| Measure |
Group I Ranibizumab 0.5 mg TER
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Overall Study
STARTED
|
323
|
327
|
|
Overall Study
Safety Set
|
323
|
326
|
|
Overall Study
COMPLETED
|
290
|
295
|
|
Overall Study
NOT COMPLETED
|
33
|
32
|
Reasons for withdrawal
| Measure |
Group I Ranibizumab 0.5 mg TER
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Protocol deviation
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
14
|
17
|
|
Overall Study
Adverse Event
|
9
|
2
|
|
Overall Study
Death
|
3
|
4
|
Baseline Characteristics
Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD
Baseline characteristics by cohort
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
Total
n=650 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.3 Years
STANDARD_DEVIATION 8.61 • n=93 Participants
|
75.2 Years
STANDARD_DEVIATION 8.13 • n=4 Participants
|
75.2 Years
STANDARD_DEVIATION 8.37 • n=27 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=93 Participants
|
181 Participants
n=4 Participants
|
360 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=93 Participants
|
146 Participants
n=4 Participants
|
290 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to month 12Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=320 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12
|
6.2 Letters (EDTRS)
Standard Error 0.70
|
8.1 Letters (EDTRS)
Standard Error 0.70
|
SECONDARY outcome
Timeframe: From Month1 to Month 11Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was analyzed.
The number of visits scheduled according to the treat and extend regimen after treatment initiation
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Number of Visits Scheduled
|
8.9 Number of visits
Standard Deviation 2.56
|
11.2 Number of visits
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=320 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Change in BCVA From Baseline to Month 12
|
6.4 Letters (EDTRS)
Standard Deviation 14.11
|
8.0 Letters (EDTRS)
Standard Deviation 11.61
|
SECONDARY outcome
Timeframe: Baseline and every month for 12 monthsPopulation: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and average visual acuity (VA) from month 1 to study completion were included in this analysis.
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=320 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Average BCVA Change From Baseline to Month 12
|
6.3 Letters (EDTRS)
Standard Deviation 10.50
|
7.1 Letters (EDTRS)
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: Baseline and every month for 12 monthsPopulation: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit.
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 1 (n=320, 322)
|
4.6 Letters (EDTRS)
Standard Deviation 7.56
|
4.2 Letters (EDTRS)
Standard Deviation 6.98
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 2 (n=240, 316)
|
5.5 Letters (EDTRS)
Standard Deviation 8.64
|
5.8 Letters (EDTRS)
Standard Deviation 8.58
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 3 (n=247, 311)
|
6.7 Letters (EDTRS)
Standard Deviation 9.09
|
6.7 Letters (EDTRS)
Standard Deviation 9.19
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 4 (n=213, 314)
|
7.0 Letters (EDTRS)
Standard Deviation 10.90
|
7.3 Letters (EDTRS)
Standard Deviation 9.95
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 5 (n=231, 302)
|
6.0 Letters (EDTRS)
Standard Deviation 11.34
|
7.7 Letters (EDTRS)
Standard Deviation 10.61
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
month 6 (n=205, 302)
|
6.9 Letters (EDTRS)
Standard Deviation 13.34
|
7.9 Letters (EDTRS)
Standard Deviation 10.83
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 7 (n=230, 298)
|
5.9 Letters (EDTRS)
Standard Deviation 14.25
|
7.9 Letters (EDTRS)
Standard Deviation 11.36
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 8 (n=210, 295)
|
7.5 Letters (EDTRS)
Standard Deviation 12.87
|
7.9 Letters (EDTRS)
Standard Deviation 11.34
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 9 (n=179, 295)
|
6.6 Letters (EDTRS)
Standard Deviation 13.63
|
7.6 Letters (EDTRS)
Standard Deviation 12.56
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 10 (n=202, 296)
|
6.3 Letters (EDTRS)
Standard Deviation 13.44
|
7.6 Letters (EDTRS)
Standard Deviation 12.06
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 11 (n=180, 290)
|
5.9 Letters (EDTRS)
Standard Deviation 14.12
|
7.5 Letters (EDTRS)
Standard Deviation 12.48
|
|
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Month 12 (n=294, 295)
|
6.6 Letters (EDTRS)
Standard Deviation 13.41
|
7.9 Letters (EDTRS)
Standard Deviation 11.96
|
SECONDARY outcome
Timeframe: Baseline and every month for 12 monthsPopulation: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 9, Gain of >= 30 letters
|
5 Number of participants
|
8 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 10, Gain of >= 1 letter (n=159, 296)
|
113 Number of participants
|
230 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 7, Gain of >= 30 letters
|
7 Number of participants
|
9 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 9, Gain of >= 15 letters
|
28 Number of participants
|
70 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 8, Gain of >= 1 letter (n=163, 295)
|
124 Number of participants
|
228 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 8, Gain of >= 5 letters
|
108 Number of participants
|
198 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 8, Gain of >= 10 letters
|
69 Number of participants
|
130 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 8, Gain of >= 15 letters
|
40 Number of participants
|
72 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 8, Gain of >= 30 letters
|
4 Number of participants
|
9 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 9, Gain of >= 1 letter (n=129, 295)
|
93 Number of participants
|
229 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 9, Gain of >= 5 letters
|
78 Number of participants
|
186 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 9, Gain of >= 10 letters
|
52 Number of participants
|
128 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 1,Gain of ≥ 1 letter (n=320,322)
|
235 Number of participants
|
233 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 1, Gain of ≥ 5 letters
|
145 Number of participants
|
145 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 1, Gain of ≥ 10 letters
|
65 Number of participants
|
58 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 1, Gain of ≥ 15 letters
|
24 Number of participants
|
23 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 1, Gain of ≥ 30 letters
|
4 Number of participants
|
2 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 2, Gain of >= 1 letter (n=226, 316)
|
168 Number of participants
|
244 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 2, Gain of >= 5 letters
|
123 Number of participants
|
184 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 2, Gain of >= 10 letters
|
60 Number of participants
|
88 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 2, Gain of >= 15 letters
|
30 Number of participants
|
39 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 2, Gain of >= 30 letters
|
4 Number of participants
|
3 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 3, Gain of >= 1 letter (n=161,311)
|
120 Number of participants
|
244 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 3, Gain of >= 5 letters
|
98 Number of participants
|
187 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 3, Gain of >= 10 letters
|
57 Number of participants
|
110 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 3, Gain of >= 15 letters
|
28 Number of participants
|
46 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 3, Gain of >= 30 letters
|
2 Number of participants
|
3 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 4, Gain of >= 1 letter (n=128, 314)
|
96 Number of participants
|
249 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 4, Gain of >= 5 letters
|
67 Number of participants
|
198 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 4, Gain of >=10 letters
|
48 Number of participants
|
118 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 4, Gain of >= 15 letters
|
25 Number of participants
|
60 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 4, Gain of >= 30 letters
|
4 Number of participants
|
8 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 5, Gain of >= 1 letter (n=114, 302)
|
84 Number of participants
|
243 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 5, Gain of >= 5 letters
|
64 Number of participants
|
197 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 5, Gain of >= 10 letters
|
42 Number of participants
|
116 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 5, Gain of >= 15 letters
|
19 Number of participants
|
59 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 5, Gain of >= 30 letters
|
3 Number of participants
|
10 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 6, Gain of >= 1 letter (n=117, 302)
|
85 Number of participants
|
238 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 6, Gain of >= 5 letters
|
68 Number of participants
|
197 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 6, Gain of >= 10 letters
|
42 Number of participants
|
125 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 6, Gain of >= 15 letters
|
19 Number of participants
|
61 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 6, Gain of >= 30 letters
|
2 Number of participants
|
11 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 7, Gain of >= 1 letter (n=176, 298)
|
126 Number of participants
|
235 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 7, Gain of >= 5 letters
|
94 Number of participants
|
196 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 7, Gain of >= 10 letters
|
57 Number of participants
|
123 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 7, Gain of >= 15 letters
|
33 Number of participants
|
69 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 10, Gain of >= 5 letters
|
98 Number of participants
|
190 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 10, Gain of >= 10 letters
|
60 Number of participants
|
126 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 10, Gain of >= 15 letters
|
32 Number of participants
|
74 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 10, Gain of >= 30 letters
|
4 Number of participants
|
10 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 11, Gain of >= 1 letter (131, 290)
|
94 Number of participants
|
222 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 11, Gain of >= 5 letters
|
79 Number of participants
|
187 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 11, Gain of >= 10 letters
|
51 Number of participants
|
130 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 11, Gain of >= 15 letters
|
32 Number of participants
|
74 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 11, Gain of >= 30 letters
|
5 Number of participants
|
9 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 12, Gain of >= 1 letter (n=291, 295)
|
217 Number of participants
|
226 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 12, Gain of >= 5 letters
|
178 Number of participants
|
199 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 12, Gain of >= 10 letters
|
123 Number of participants
|
135 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 12, Gain of >= 15 letters
|
75 Number of participants
|
77 Number of participants
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
Month 12, Gain of >= 30 letters
|
12 Number of participants
|
8 Number of participants
|
SECONDARY outcome
Timeframe: Baseline and every month for 12 monthsPopulation: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 1, Loss of < 5 letters (n=320, 322)
|
296 Number of participants
|
295 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 1, Loss of < 10 letters
|
313 Number of participants
|
314 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 1, Loss of < 15 letters
|
319 Number of participants
|
320 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 2, Loss of < 5 letters (n=226, 316)
|
205 Number of participants
|
288 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 2, Loss of < 10 letters
|
220 Number of participants
|
306 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 2, Loss of < 15 letters
|
223 Number of participants
|
309 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 3, Loss of < 5 letters (n=161, 311)
|
146 Number of participants
|
289 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 3, Loss of < 10 letters
|
158 Number of participants
|
299 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 3, Loss of < 15 letters
|
160 Number of participants
|
304 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 4, Loss of < 5 letters (n=128, 314)
|
114 Number of participants
|
286 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 4, Loss of < 10 letters
|
128 Number of participants
|
301 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 4, Loss of < 15 letters
|
124 Number of participants
|
307 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 5, Loss of < 5 letters (n=114, 302)
|
97 Number of participants
|
276 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 5, Loss of < 10 letters
|
105 Number of participants
|
287 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 5, Loss of < 15 letters
|
108 Number of participants
|
295 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 6, Loss of < 5 letters (n=117, 302)
|
104 Number of participants
|
271 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 6, Loss of < 10 letters
|
110 Number of participants
|
286 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 6, Loss of < 15 letters
|
111 Number of participants
|
298 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 7, Loss of < 5 letters (n=176, 298)
|
148 Number of participants
|
268 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 7, Loss of < 10 letters
|
162 Number of participants
|
279 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 7, Loss of < 15 letters
|
166 Number of participants
|
289 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 8, Loss of < 5 letters (n=163, 295)
|
145 Number of participants
|
262 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 8, Loss of < 10 letters
|
155 Number of participants
|
276 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 8, Loss of < 15 letters
|
155 Number of participants
|
286 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 9, Loss of < 5 letters (n=129, 295)
|
110 Number of participants
|
258 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 9, Loss of < 10 letters
|
120 Number of participants
|
270 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 9, Loss of < 15 letters
|
122 Number of participants
|
281 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 10, Loss of < 5 letters(n=159, 296)
|
133 Number of participants
|
253 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 10, Loss of < 10 letters
|
147 Number of participants
|
276 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 10, Loss of < 15 letters
|
150 Number of participants
|
285 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 11, Loss of < 5 letters (n=131, 290)
|
105 Number of participants
|
251 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 11, Loss of < 10 letters
|
118 Number of participants
|
263 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 11, Loss of < 15 letters
|
121 Number of participants
|
275 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 12, Loss of < 5 letters (291, 295)
|
247 Number of participants
|
256 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 12, Loss of < 10 letters
|
267 Number of participants
|
272 Number of participants
|
|
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
Month 12, Loss of < 15 letters
|
273 Number of participants
|
284 Number of participants
|
SECONDARY outcome
Timeframe: Baseline and every month for 12 monthsPopulation: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 1 (n=320, 322)
|
106 Number of participants
|
106 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 2 (n=226, 316)
|
74 Number of participants
|
136 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 3 (n=161, 311)
|
67 Number of participants
|
148 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 4 (n=128, 314)
|
60 Number of participants
|
147 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 5 (n=114, 302)
|
51 Number of participants
|
156 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 6 (n=117, 302)
|
58 Number of participants
|
155 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 7 (n=176, 298)
|
78 Number of participants
|
150 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 8 (n=163, 295)
|
84 Number of participants
|
155 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 9 (n=129, 295)
|
68 Number of participants
|
156 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 10 (n=159, 296)
|
74 Number of participants
|
149 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 11 (n=131, 290
|
63 Number of participants
|
143 Number of participants
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Month 12 (n=291, 295)
|
131 Number of participants
|
149 Number of participants
|
SECONDARY outcome
Timeframe: Month 12Population: Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization
The number of injections received
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
The Mean Number of Treatment Frequency
|
8.7 Number of injections
Standard Deviation 2.68
|
11.0 Number of injections
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Month 12Population: Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization
The average dosing interval was measured as the average number of days between injections
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
The Average Number of Days Between Injections
|
40.3 days
Standard Deviation 11.28
|
29.4 days
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Month 12Population: Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization
OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=291 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=290 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Percentage of Participants With Fluid Free Macula Over Time up to Month 12
Absent
|
60.5 Percentage of participants
|
60.7 Percentage of participants
|
|
Percentage of Participants With Fluid Free Macula Over Time up to Month 12
Definite
|
39.5 Percentage of participants
|
39 Percentage of participants
|
|
Percentage of Participants With Fluid Free Macula Over Time up to Month 12
Can't grade
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Month 12Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.
OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=327 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 1 (n=311, 316)
|
-137.6 microns
Standard Deviation 132.33
|
-126.8 microns
Standard Deviation 119.47
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 2 (n=220, 311)
|
-151.6 microns
Standard Deviation 151.15
|
-149.2 microns
Standard Deviation 137.60
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 3 (n=157, 304)
|
-149.8 microns
Standard Deviation 167.26
|
-151.8 microns
Standard Deviation 149.51
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 4 (n=125, 307)
|
-141.8 microns
Standard Deviation 183.71
|
-161.3 microns
Standard Deviation 149.36
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 5 (n=110, 295)
|
-138.6 microns
Standard Deviation 160.04
|
-160.9 microns
Standard Deviation 148.23
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 6 (n=113, 298)
|
-140.1 microns
Standard Deviation 156.25
|
-163.4 microns
Standard Deviation 157.18
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 7 (n=173, 296)
|
-146.6 microns
Standard Deviation 160.72
|
-166.9 microns
Standard Deviation 161.49
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 8 (n=159, 290)
|
-153.4 microns
Standard Deviation 151.93
|
-170.4 microns
Standard Deviation 156.68
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 9 (n=126, 286)
|
-150.2 microns
Standard Deviation 153.82
|
-169.3 microns
Standard Deviation 156.50
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 10 (n=156, 291)
|
-154.6 microns
Standard Deviation 162.77
|
-170.9 microns
Standard Deviation 153.90
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 11 (n=127, 285)
|
-133.1 microns
Standard Deviation 170.47
|
-174.8 microns
Standard Deviation 163.16
|
|
Change in Central Subfield Retinal Thickness (CSFT) Over Time
Month 12 (n=289, 287)
|
-172.1 microns
Standard Deviation 162.81
|
-173.3 microns
Standard Deviation 154.13
|
SECONDARY outcome
Timeframe: Month 12Population: Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization.
To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages.
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=278 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=286 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at
Yes
|
18.7 Percentage of participants
|
17.1 Percentage of participants
|
|
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at
No
|
74.1 Percentage of participants
|
76.9 Percentage of participants
|
|
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at
Can't grade
|
0.0 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at
Not applicable
|
7.2 Percentage of participants
|
3.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and post-baseline value at the specific visit were included for this analysis
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome
Outcome measures
| Measure |
Group I Ranibizumab 0.5 mg TER
n=290 Participants
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=293 Participants
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)
|
2.3 Score on a scale
Standard Deviation 13.93
|
4 Score on a scale
Standard Deviation 13.72
|
Adverse Events
Group I Ranibizumab 0.5 mg TER
Serious events: 39 serious events
Other events: 164 other events
Deaths: 0 deaths
Group II Ranibizumab 0.5 mg Monthly
Serious events: 42 serious events
Other events: 166 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 participants at risk
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=326 participants at risk
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/323
|
0.31%
1/326
|
|
Cardiac disorders
Acute coronary syndrome
|
0.31%
1/323
|
0.00%
0/326
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
1/323
|
0.00%
0/326
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
1/323
|
0.00%
0/326
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/323
|
0.31%
1/326
|
|
Cardiac disorders
Cardiac failure
|
0.31%
1/323
|
0.31%
1/326
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/323
|
0.31%
1/326
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/323
|
0.31%
1/326
|
|
Cardiac disorders
Myocardial infarction
|
0.62%
2/323
|
0.00%
0/326
|
|
Cardiac disorders
Palpitations
|
0.31%
1/323
|
0.00%
0/326
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/323
|
0.31%
1/326
|
|
Ear and labyrinth disorders
Vertigo
|
0.62%
2/323
|
0.00%
0/326
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/323
|
0.31%
1/326
|
|
Endocrine disorders
Hyperthyroidism
|
0.31%
1/323
|
0.00%
0/326
|
|
Eye disorders
Cataract (Fellow eye)
|
0.31%
1/323
|
0.00%
0/326
|
|
Eye disorders
Corneal erosion (Study eye)
|
0.31%
1/323
|
0.00%
0/326
|
|
Eye disorders
Corneal infiltrates (Study eye)
|
0.31%
1/323
|
0.00%
0/326
|
|
Eye disorders
Dacryostenosis acquired (Fellow eye)
|
0.00%
0/323
|
0.31%
1/326
|
|
Eye disorders
Dacryostenosis acquired (Study eye)
|
0.00%
0/323
|
0.31%
1/326
|
|
Eye disorders
Macular hole (Study eye)
|
0.00%
0/323
|
0.31%
1/326
|
|
Eye disorders
Retinal detachment (Study eye)
|
0.31%
1/323
|
0.00%
0/326
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
0.31%
1/323
|
0.00%
0/326
|
|
Eye disorders
Retinal tear (Study eye)
|
0.31%
1/323
|
0.00%
0/326
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.31%
1/323
|
0.00%
0/326
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/323
|
0.31%
1/326
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/323
|
0.31%
1/326
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.31%
1/323
|
0.00%
0/326
|
|
Gastrointestinal disorders
Vomiting
|
0.31%
1/323
|
0.31%
1/326
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/323
|
0.31%
1/326
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/323
|
0.31%
1/326
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.31%
1/323
|
0.00%
0/326
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/323
|
0.31%
1/326
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/323
|
0.31%
1/326
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Bronchitis
|
0.62%
2/323
|
0.00%
0/326
|
|
Infections and infestations
Cellulitis
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Diverticulitis
|
0.31%
1/323
|
0.31%
1/326
|
|
Infections and infestations
Endophthalmitis (Fellow eye)
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Endophthalmitis (Study eye)
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Erysipelas
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Paronychia
|
0.31%
1/323
|
0.00%
0/326
|
|
Infections and infestations
Pneumonia
|
1.2%
4/323
|
0.61%
2/326
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.31%
1/323
|
0.00%
0/326
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Pyelonephritis acute
|
0.31%
1/323
|
0.00%
0/326
|
|
Infections and infestations
Sinusitis
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/323
|
0.31%
1/326
|
|
Infections and infestations
Urosepsis
|
0.00%
0/323
|
0.31%
1/326
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/323
|
0.31%
1/326
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/323
|
0.31%
1/326
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.62%
2/323
|
0.00%
0/326
|
|
Injury, poisoning and procedural complications
Head injury
|
0.31%
1/323
|
0.31%
1/326
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.31%
1/323
|
0.00%
0/326
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/323
|
0.31%
1/326
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/323
|
0.31%
1/326
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/323
|
0.31%
1/326
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.31%
1/323
|
0.00%
0/326
|
|
Investigations
Blood pressure decreased
|
0.00%
0/323
|
0.31%
1/326
|
|
Investigations
Intraocular pressure increased (Fellow eye)
|
0.00%
0/323
|
0.31%
1/326
|
|
Investigations
Intraocular pressure increased (Study eye)
|
0.00%
0/323
|
0.31%
1/326
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/323
|
0.31%
1/326
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.31%
1/323
|
0.00%
0/326
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.31%
1/323
|
0.00%
0/326
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.31%
1/323
|
0.00%
0/326
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
1/323
|
0.00%
0/326
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.31%
1/323
|
0.00%
0/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/323
|
0.31%
1/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.31%
1/323
|
0.00%
0/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.31%
1/323
|
0.00%
0/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.31%
1/323
|
0.00%
0/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/323
|
0.61%
2/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.31%
1/323
|
0.00%
0/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/323
|
0.31%
1/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.31%
1/323
|
0.00%
0/326
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/323
|
0.31%
1/326
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.31%
1/323
|
0.00%
0/326
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/323
|
0.61%
2/326
|
|
Nervous system disorders
Dizziness
|
0.00%
0/323
|
0.31%
1/326
|
|
Nervous system disorders
Hemiparesis
|
0.31%
1/323
|
0.00%
0/326
|
|
Nervous system disorders
Intracranial aneurysm
|
0.31%
1/323
|
0.00%
0/326
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/323
|
0.31%
1/326
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/323
|
0.31%
1/326
|
|
Nervous system disorders
Sciatica
|
0.00%
0/323
|
0.61%
2/326
|
|
Nervous system disorders
Syncope
|
0.31%
1/323
|
0.31%
1/326
|
|
Nervous system disorders
Transient ischaemic attack
|
0.93%
3/323
|
0.31%
1/326
|
|
Nervous system disorders
VIth nerve paresis
|
0.00%
0/323
|
0.31%
1/326
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/323
|
0.31%
1/326
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/323
|
0.31%
1/326
|
|
Renal and urinary disorders
Haematuria
|
0.31%
1/323
|
0.00%
0/326
|
|
Renal and urinary disorders
Hydronephrosis
|
0.31%
1/323
|
0.00%
0/326
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
1/323
|
0.31%
1/326
|
|
Renal and urinary disorders
Urinary incontinence
|
0.31%
1/323
|
0.00%
0/326
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/323
|
0.31%
1/326
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/323
|
0.31%
1/326
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.62%
2/323
|
0.31%
1/326
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
2/323
|
0.31%
1/326
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.31%
1/323
|
0.00%
0/326
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.31%
1/323
|
0.00%
0/326
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.31%
1/323
|
0.00%
0/326
|
|
Vascular disorders
Deep vein thrombosis
|
0.31%
1/323
|
0.31%
1/326
|
|
Vascular disorders
Hypertensive crisis
|
0.31%
1/323
|
0.00%
0/326
|
|
Vascular disorders
Hypotension
|
0.62%
2/323
|
0.00%
0/326
|
Other adverse events
| Measure |
Group I Ranibizumab 0.5 mg TER
n=323 participants at risk
Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
|
Group II Ranibizumab 0.5 mg Monthly
n=326 participants at risk
Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
|
|---|---|---|
|
Eye disorders
Age-related macular degeneration (Fellow eye)
|
2.8%
9/323
|
1.2%
4/326
|
|
Eye disorders
Blepharitis (Fellow eye)
|
1.9%
6/323
|
2.5%
8/326
|
|
Eye disorders
Blepharitis (Study eye)
|
1.5%
5/323
|
1.8%
6/326
|
|
Eye disorders
Cataract (Fellow eye)
|
2.2%
7/323
|
3.1%
10/326
|
|
Eye disorders
Cataract (Study eye)
|
2.2%
7/323
|
2.1%
7/326
|
|
Eye disorders
Choroidal neovascularisation (Fellow eye)
|
1.9%
6/323
|
2.1%
7/326
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
4.3%
14/323
|
5.8%
19/326
|
|
Eye disorders
Detachment of retinal pigment epithelium (Study eye)
|
0.00%
0/323
|
1.2%
4/326
|
|
Eye disorders
Dry eye (Fellow eye)
|
2.2%
7/323
|
1.8%
6/326
|
|
Eye disorders
Dry eye (Study eye)
|
1.9%
6/323
|
2.1%
7/326
|
|
Eye disorders
Eye pain (Study eye)
|
3.1%
10/323
|
1.5%
5/326
|
|
Eye disorders
Neovascular age-related macular degeneration (Fellow eye)
|
2.5%
8/323
|
4.9%
16/326
|
|
Eye disorders
Ocular hypertension (Study eye)
|
1.2%
4/323
|
1.2%
4/326
|
|
Eye disorders
Punctate keratitis (Study eye)
|
1.2%
4/323
|
0.92%
3/326
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
1.5%
5/323
|
2.5%
8/326
|
|
Eye disorders
Retinal pigment epithelial tear (Study eye)
|
1.2%
4/323
|
0.92%
3/326
|
|
Eye disorders
Visual acuity reduced (Fellow eye)
|
1.9%
6/323
|
1.2%
4/326
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
4.6%
15/323
|
3.7%
12/326
|
|
Eye disorders
Vitreous floaters (Study eye)
|
0.31%
1/323
|
1.2%
4/326
|
|
Gastrointestinal disorders
Nausea
|
1.2%
4/323
|
1.5%
5/326
|
|
General disorders
Oedema peripheral
|
0.00%
0/323
|
1.5%
5/326
|
|
Infections and infestations
Bronchitis
|
1.9%
6/323
|
3.7%
12/326
|
|
Infections and infestations
Conjunctivitis (Fellow eye)
|
1.9%
6/323
|
1.8%
6/326
|
|
Infections and infestations
Conjunctivitis (Study eye)
|
3.1%
10/323
|
1.8%
6/326
|
|
Infections and infestations
Cystitis
|
0.93%
3/323
|
1.2%
4/326
|
|
Infections and infestations
Influenza
|
2.8%
9/323
|
3.7%
12/326
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
18/323
|
8.0%
26/326
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
5/323
|
0.92%
3/326
|
|
Infections and infestations
Sinusitis
|
0.31%
1/323
|
1.2%
4/326
|
|
Infections and infestations
Urinary tract infection
|
1.5%
5/323
|
0.61%
2/326
|
|
Investigations
Blood pressure increased
|
1.2%
4/323
|
0.31%
1/326
|
|
Investigations
Intraocular pressure increased (Fellow eye)
|
0.93%
3/323
|
2.5%
8/326
|
|
Investigations
Intraocular pressure increased (Study eye)
|
8.4%
27/323
|
8.6%
28/326
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
4/323
|
1.8%
6/326
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
4/323
|
1.5%
5/326
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
4/323
|
1.2%
4/326
|
|
Nervous system disorders
Dizziness
|
1.5%
5/323
|
0.31%
1/326
|
|
Nervous system disorders
Headache
|
1.2%
4/323
|
1.2%
4/326
|
|
Nervous system disorders
Sciatica
|
1.9%
6/323
|
0.31%
1/326
|
|
Psychiatric disorders
Depression
|
0.62%
2/323
|
1.2%
4/326
|
|
Psychiatric disorders
Insomnia
|
1.5%
5/323
|
0.00%
0/326
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
4/323
|
0.00%
0/326
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
5/323
|
0.61%
2/326
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.62%
2/323
|
1.8%
6/326
|
|
Vascular disorders
Hypertension
|
7.1%
23/323
|
4.0%
13/326
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER