Trial Outcomes & Findings for A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients (NCT NCT02259088)
NCT ID: NCT02259088
Last Updated: 2019-02-01
Results Overview
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged \[(Month1+Month2+...+Month12)/12\], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
COMPLETED
PHASE3
384 participants
Baseline, Monthly from Month 1 through Month 12
2019-02-01
Participant Flow
After eligibility confirmation, patients were randomized in a 4:1 ratio to 2 treatment arms.
Participant milestones
| Measure |
Ranibizumab (RFB002)
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Overall Study
STARTED
|
307
|
77
|
|
Overall Study
Full Analysis Set
|
307
|
77
|
|
Overall Study
Treated (Safety Analysis Set)
|
307
|
75
|
|
Overall Study
COMPLETED
|
279
|
63
|
|
Overall Study
NOT COMPLETED
|
28
|
14
|
Reasons for withdrawal
| Measure |
Ranibizumab (RFB002)
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Physician Decision
|
5
|
2
|
|
Overall Study
Protocol deviation
|
5
|
0
|
|
Overall Study
Subject/guardian decision
|
8
|
8
|
Baseline Characteristics
A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
Baseline characteristics by cohort
| Measure |
Ranibizumab (RFB002)
n=307 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=77 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 9.19 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Best Corrected Visual Acuity
|
59.6 letters
STANDARD_DEVIATION 10.53 • n=5 Participants
|
58.2 letters
STANDARD_DEVIATION 9.43 • n=7 Participants
|
59.3 letters
STANDARD_DEVIATION 10.32 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Monthly from Month 1 through Month 12Population: Full Analysis Set (FAS). Missing values imputed by the mean value last observation carried forward (MV-LOCF).
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged \[(Month1+Month2+...+Month12)/12\], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=303 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12
|
6.8 letters
Standard Deviation 6.58
|
1.1 letters
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Baseline, Monthly from Month 1 through Month 12Population: Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=303 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 1
|
4.0 letters
Standard Deviation 5.59
|
-0.9 letters
Standard Deviation 5.50
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 2
|
5.8 letters
Standard Deviation 6.44
|
0.0 letters
Standard Deviation 8.08
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 3
|
6.9 letters
Standard Deviation 6.91
|
1.1 letters
Standard Deviation 9.18
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 4
|
6.6 letters
Standard Deviation 7.23
|
0.0 letters
Standard Deviation 11.64
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 5
|
6.8 letters
Standard Deviation 7.41
|
0.6 letters
Standard Deviation 10.61
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 6
|
6.8 letters
Standard Deviation 8.00
|
0.3 letters
Standard Deviation 11.01
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 7
|
6.8 letters
Standard Deviation 7.95
|
1.3 letters
Standard Deviation 10.13
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 8
|
7.4 letters
Standard Deviation 8.12
|
1.9 letters
Standard Deviation 9.69
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 9
|
7.3 letters
Standard Deviation 8.18
|
1.8 letters
Standard Deviation 9.33
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 10
|
7.2 letters
Standard Deviation 8.45
|
1.6 letters
Standard Deviation 9.23
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 11
|
7.8 letters
Standard Deviation 8.55
|
1.7 letters
Standard Deviation 9.35
|
|
Mean Change From Baseline in BCVA (Letters) at Each Visit
Change from Baseline at Month 12
|
7.8 letters
Standard Deviation 8.72
|
2.5 letters
Standard Deviation 8.78
|
SECONDARY outcome
Timeframe: Baseline, Monthly from Month 1 through Month 12Population: Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT). A negative change value indicates an improvement in macular edema, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=301 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 1
|
-126.7 micrometers
Standard Deviation 140.59
|
-33.1 micrometers
Standard Deviation 113.34
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 2
|
-141.3 micrometers
Standard Deviation 146.15
|
-48.8 micrometers
Standard Deviation 133.22
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 3
|
-154.2 micrometers
Standard Deviation 147.94
|
-58.5 micrometers
Standard Deviation 157.30
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 4
|
-130.4 micrometers
Standard Deviation 152.60
|
-72.6 micrometers
Standard Deviation 149.13
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 5
|
-141.0 micrometers
Standard Deviation 153.28
|
-72.3 micrometers
Standard Deviation 150.45
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 6
|
-146.2 micrometers
Standard Deviation 154.87
|
-72.9 micrometers
Standard Deviation 152.47
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 7
|
-138.4 micrometers
Standard Deviation 161.04
|
-72.4 micrometers
Standard Deviation 150.86
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 8
|
-146.9 micrometers
Standard Deviation 154.68
|
-81.8 micrometers
Standard Deviation 151.89
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 9
|
-142.4 micrometers
Standard Deviation 156.03
|
-80.9 micrometers
Standard Deviation 157.69
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 10
|
-137.6 micrometers
Standard Deviation 152.73
|
-82.9 micrometers
Standard Deviation 166.16
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 11
|
-144.8 micrometers
Standard Deviation 159.87
|
-88.1 micrometers
Standard Deviation 170.11
|
|
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Change from Baseline at Month 12
|
-146.5 micrometers
Standard Deviation 157.61
|
-85.9 micrometers
Standard Deviation 166.60
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=303 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12
Gain of ≥ 10 letters
|
40.6 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12
Gain of ≥ 15 letters
|
18.5 percentage of participants
|
8.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=303 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12
Loss of < 10 letters
|
97.0 percentage of participants
|
89.3 percentage of participants
|
|
Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12
Loss of <15 letters
|
99.0 percentage of participants
|
97.3 percentage of participants
|
SECONDARY outcome
Timeframe: Month 12Population: Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=303 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Percentage of Patients With BCVA ≥ 73 Letters at Month 12
|
36.0 percentage of participants
|
21.3 percentage of participants
|
SECONDARY outcome
Timeframe: Monthly from Month 3 through Month 12Population: Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged \[(Month4+Month5+...+Month12)/9\],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=303 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3
Month 3
|
66.4 letters
Standard Deviation 10.66
|
59.2 letters
Standard Deviation 12.63
|
|
Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3
Average Change from Baseline Month 4 to Month 12
|
0.3 letters
Standard Deviation 4.51
|
0.2 letters
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score
Change from Baseline at Month 6
|
2.5 units on a scale
Standard Deviation 13.54
|
0.5 units on a scale
Standard Deviation 13.17
|
|
Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score
Change from Baseline at Month 12
|
0.6 units on a scale
Standard Deviation 14.99
|
-0.4 units on a scale
Standard Deviation 15.89
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
General health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general health, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12
Change from Baseline at Month 6
|
-1.5 units on a scale
Standard Deviation 22.32
|
-0.4 units on a scale
Standard Deviation 21.81
|
|
Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12
Change from Baseline at Month 12
|
-2.3 units on a scale
Standard Deviation 24.34
|
-4.3 units on a scale
Standard Deviation 26.56
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
General vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general vision, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12
Change from Baseline at Month 6
|
6.2 units on a scale
Standard Deviation 18.77
|
4.7 units on a scale
Standard Deviation 19.58
|
|
Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12
Change from Baseline at Month 12
|
5.9 units on a scale
Standard Deviation 18.12
|
5.9 units on a scale
Standard Deviation 20.06
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations).The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Color vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in color vision, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=280 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=67 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12
Change from Baseline at Month 6
|
2.0 units on a scale
Standard Deviation 16.68
|
2.2 units on a scale
Standard Deviation 17.26
|
|
Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12
Change from Baseline at Month 12
|
0.2 units on a scale
Standard Deviation 21.55
|
1.6 units on a scale
Standard Deviation 20.35
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Peripheral vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in peripheral vision, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=291 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12
Change from Baseline at Month 6
|
1.4 units on a scale
Standard Deviation 20.51
|
5.5 units on a scale
Standard Deviation 22.38
|
|
Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12
Change from Baseline at Month 12
|
-2.3 units on a scale
Standard Deviation 25.07
|
3.1 units on a scale
Standard Deviation 27.64
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Ocular pain was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in ocular pain, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12
Change from Baseline at Month 6
|
-1.5 units on a scale
Standard Deviation 20.71
|
1.5 units on a scale
Standard Deviation 20.89
|
|
Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12
Change from Baseline at Month 12
|
-0.3 units on a scale
Standard Deviation 19.89
|
4.1 units on a scale
Standard Deviation 22.72
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Near activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in near activities, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=291 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12
Change from Baseline at Month 6
|
5.6 units on a scale
Standard Deviation 23.81
|
-1.7 units on a scale
Standard Deviation 24.20
|
|
Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12
Change from Baseline at Month 12
|
0.6 units on a scale
Standard Deviation 24.64
|
-3.4 units on a scale
Standard Deviation 21.93
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Distance activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in distance activities, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12
Change from Baseline at Month 6
|
5.4 units on a scale
Standard Deviation 20.79
|
-2.8 units on a scale
Standard Deviation 19.35
|
|
Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12
Change from Baseline at Month 12
|
1.6 units on a scale
Standard Deviation 23.74
|
-5.5 units on a scale
Standard Deviation 21.89
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Social functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in social functioning, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=67 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12
Change from Baseline at Month 12
|
-0.8 units on a scale
Standard Deviation 21.58
|
-3.2 units on a scale
Standard Deviation 18.51
|
|
Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12
Change from Baseline at Month 6
|
2.1 units on a scale
Standard Deviation 19.24
|
-1.5 units on a scale
Standard Deviation 15.31
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Mental health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in mental health, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12
Change from Baseline at Month 6
|
1.8 units on a scale
Standard Deviation 23.07
|
-0.2 units on a scale
Standard Deviation 23.58
|
|
Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12
Change from Baseline at Month 12
|
1.3 units on a scale
Standard Deviation 25.05
|
0.6 units on a scale
Standard Deviation 23.32
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Roles difficulties were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in roles difficulties, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12
Change from Baseline at Month 6
|
1.4 units on a scale
Standard Deviation 27.05
|
-0.4 units on a scale
Standard Deviation 24.24
|
|
Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12
Change from Baseline at Month 12
|
0.4 units on a scale
Standard Deviation 27.62
|
-1.4 units on a scale
Standard Deviation 28.36
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Dependency was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in dependency, while a negative change value indicates a worsening.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=292 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=68 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12
Change from Baseline at Month 6
|
0.2 units on a scale
Standard Deviation 27.95
|
-4.3 units on a scale
Standard Deviation 27.53
|
|
Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12
Change from Baseline at Month 12
|
0.9 units on a scale
Standard Deviation 30.47
|
-5.3 units on a scale
Standard Deviation 27.87
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Full Analysis Set, observed data (no missing data imputations).The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.
Driving was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in driving, while a negative change value indicates a worsening. Note: Many patients did not answer the driving related question as they did not drive at all.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=44 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=12 Participants
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12
Change from Baseline at Month 6
|
2.8 units on a scale
Standard Deviation 15.87
|
2.8 units on a scale
Standard Deviation 20.52
|
|
Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12
Change from Baseline at Month 12
|
-0.2 units on a scale
Standard Deviation 12.29
|
4.5 units on a scale
Standard Deviation 27.98
|
SECONDARY outcome
Timeframe: Monthly from Month 3 through Month 12Population: Safety Analysis Set
A ranibizumab re-treatment was defined as an administration of ranibizumab injection at a scheduled visit following at least one non-missed visit where ranibizumab was not administered in the study eye due to visual acuity stabilization. This outcome measure was pre-specified for the Ranibizumab 0.5 mg arm only.
Outcome measures
| Measure |
Ranibizumab (RFB002)
n=301 Participants
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward
|
1.6 retreatments
Standard Deviation 0.64
|
—
|
Adverse Events
Ranibizumab (RFB002)
Laser
Serious adverse events
| Measure |
Ranibizumab (RFB002)
n=307 participants at risk
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 participants at risk
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Cardiac disorders
Angina unstable
|
0.65%
2/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
5/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Cataract (Fellow eye)
|
0.65%
2/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Cataract (Study eye)
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Diabetic retinal oedema (Fellow eye)
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
2.7%
2/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Diabetic retinopathy (Fellow eye)
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Eye haemorrhage (Fellow eye)
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Glaucoma (Fellow eye)
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Retinal detachment (Fellow eye)
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Vitreous haemorrhage (Fellow eye)
|
0.98%
3/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
General disorders
Sudden death
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Chronic sinusitis
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Conjunctivitis viral (Fellow eye)
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Herpes zoster
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Lung infection
|
0.65%
2/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Otitis media chronic
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Periodontitis
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Pneumonia
|
0.65%
2/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory tract infection
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.3%
4/307 • Day 1 through study completion, an average of 1 year
|
2.7%
2/75 • Day 1 through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.65%
2/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal flattening
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Nervous system disorders
Basilar artery stenosis
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Nervous system disorders
Cerebral infarction
|
1.3%
4/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Nervous system disorders
Diabetic neuropathy
|
0.98%
3/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Nervous system disorders
Dizziness
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Nervous system disorders
Lacunar infarction
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Nervous system disorders
Syncope
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Renal and urinary disorders
Diabetic nephropathy
|
1.6%
5/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Renal and urinary disorders
Pollakiuria
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Renal and urinary disorders
Renal arteriosclerosis
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
2/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Diabetic dermopathy
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.33%
1/307 • Day 1 through study completion, an average of 1 year
|
2.7%
2/75 • Day 1 through study completion, an average of 1 year
|
|
Vascular disorders
Diabetic vascular disorder
|
0.65%
2/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Vascular disorders
Hypertension
|
0.65%
2/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
Other adverse events
| Measure |
Ranibizumab (RFB002)
n=307 participants at risk
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
|
Laser
n=75 participants at risk
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
10/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
3.6%
11/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Dry eye (Fellow eye)
|
3.3%
10/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Dry eye (Study eye)
|
3.6%
11/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Vitreous haemorrhage (Fellow eye)
|
3.6%
11/307 • Day 1 through study completion, an average of 1 year
|
4.0%
3/75 • Day 1 through study completion, an average of 1 year
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
1.6%
5/307 • Day 1 through study completion, an average of 1 year
|
4.0%
3/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
20/307 • Day 1 through study completion, an average of 1 year
|
9.3%
7/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
8.5%
26/307 • Day 1 through study completion, an average of 1 year
|
2.7%
2/75 • Day 1 through study completion, an average of 1 year
|
|
Infections and infestations
Urinary tract infection
|
4.9%
15/307 • Day 1 through study completion, an average of 1 year
|
4.0%
3/75 • Day 1 through study completion, an average of 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.98%
3/307 • Day 1 through study completion, an average of 1 year
|
5.3%
4/75 • Day 1 through study completion, an average of 1 year
|
|
Investigations
Intraocular pressure increased (Study eye)
|
5.2%
16/307 • Day 1 through study completion, an average of 1 year
|
0.00%
0/75 • Day 1 through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.9%
9/307 • Day 1 through study completion, an average of 1 year
|
4.0%
3/75 • Day 1 through study completion, an average of 1 year
|
|
Renal and urinary disorders
Diabetic nephropathy
|
3.3%
10/307 • Day 1 through study completion, an average of 1 year
|
1.3%
1/75 • Day 1 through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
18/307 • Day 1 through study completion, an average of 1 year
|
2.7%
2/75 • Day 1 through study completion, an average of 1 year
|
|
Vascular disorders
Hypertension
|
5.5%
17/307 • Day 1 through study completion, an average of 1 year
|
12.0%
9/75 • Day 1 through study completion, an average of 1 year
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER