Central Retinal Vein Occlusion
Conditions
Keywords
CRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab
Brief summary
Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO
Interventions
OTHERSham injection
Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.
Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for study and fellow eye: • Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a BCVA between 24 and 73 letters in one eye and at least 35 letters in the other eye.
Exclusion criteria
* Pregnant or nursing women or women of child bearing potential unless using an effective contraception \- Stroke or myocard infarction within 3 months prior to study * History of malignancy within the past 5 years * Uncontrolled hypertension * Active infection or inflammation in any eye * use of corticosteroids for at least 30 days in the last 6 months * treatment with anti-angiogenic drugs in any eye within last 3 months * Panretinal or focal/drid laser photocoagulation within the last 3 and 4 months respectively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 | Baseline, 3 Months | 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 month 1 to month 3 and compared to Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 | Baseline, 12 months | 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 month 1 to month 12 and compared to Baseline |
| Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 1 to 12 months | Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline |
| Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 1 to month 12 | 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. |
| Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 to month 12 | 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. |
| Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 1 to 12 months | Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline. |
| The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | Month 3,6 and 12 | The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning. |
Countries
China, Hong Kong, India, Indonesia, Philippines, Taiwan, Vietnam
Participant flow
Recruitment details
A total of 253 patients were randomized to this study, 191 patients to the ranibizumab group and 62 patients to the sham group. One patient randomized to the ranibizumab group was excluded from all analyses as informed consent was obtained after first study procedures were performed. Therefore, this patient not included in randomized set.
Pre-assignment details
This study consisted of the 3 periods (Screening period: Day -14 to Day -1; treatment period: Day 1 to Month 11; post-treatment period: Month 11 to Month 12). At Baseline (Visit 2, Day 1), eligible patients were randomized in a 3:1 ratio to one of the treatment arms
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab 0.5 mg PRN intravitreal injection | 190 |
| Sham Injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections | 62 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 2 |
Baseline characteristics
| Characteristic | Ranibizumab 0.5 mg | Sham Injection | Total |
|---|---|---|---|
| Age, Continuous | 54.1 Years STANDARD_DEVIATION 12.64 | 54.1 Years STANDARD_DEVIATION 13.29 | 54.1 Years STANDARD_DEVIATION 12.77 |
| Sex: Female, Male Female | 88 Participants | 29 Participants | 117 Participants |
| Sex: Female, Male Male | 102 Participants | 33 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 96 / 190 | 32 / 56 | 3 / 5 |
| serious Total, serious adverse events | 11 / 190 | 5 / 56 | 1 / 5 |
Outcome results
Primary
Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3
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 month 1 to month 3 and compared to Baseline.
Time frame: Baseline, 3 Months
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg | Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 | 11.3 Letters | Standard Deviation 10.77 |
| Sham Injection | Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 | -2.7 Letters | Standard Deviation 13.92 |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12
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 month 1 to month 12 and compared to Baseline
Time frame: Baseline, 12 months
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg | Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 | 12.4 Letters | Standard Deviation 11.43 |
| Sham Injection | Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 | 3.2 Letters | Standard Deviation 14.62 |
Secondary
Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time
Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline
Time frame: Month 1 to 12 months
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 1 | 9.6 Letters | Standard Deviation 10.2 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 2 | 11.6 Letters | Standard Deviation 12.39 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 3 | 12.6 Letters | Standard Deviation 12.01 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 4 | 10.7 Letters | Standard Deviation 12.56 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 5 | 11.7 Letters | Standard Deviation 12.62 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 6 | 12.3 Letters | Standard Deviation 13.1 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 7 | 12.9 Letters | Standard Deviation 13.36 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 8 | 12.4 Letters | Standard Deviation 14.01 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 9 | 13.1 Letters | Standard Deviation 15.1 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 10 | 13.5 Letters | Standard Deviation 14.13 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 11 | 14.2 Letters | Standard Deviation 13.15 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 12 | 14.5 Letters | Standard Deviation 14.25 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 11 | 6.8 Letters | Standard Deviation 16.3 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 1 | -0.9 Letters | Standard Deviation 12.17 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 7 | 5.0 Letters | Standard Deviation 16.71 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 2 | -3.4 Letters | Standard Deviation 16.04 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 10 | 5.9 Letters | Standard Deviation 16.77 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 3 | -3.8 Letters | Standard Deviation 17.02 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 8 | 6.0 Letters | Standard Deviation 16.01 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 4 | 2.8 Letters | Standard Deviation 15.26 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 12 | 6.5 Letters | Standard Deviation 17.1 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 5 | 3.9 Letters | Standard Deviation 15.26 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 9 | 5.6 Letters | Standard Deviation 16.95 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Month 6 | 3.8 Letters | Standard Deviation 17.2 |
Secondary
Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time
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.
Time frame: Month 1 to month 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 1 | -393.7 microns | Standard Deviation 275.13 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 2 | -412.6 microns | Standard Deviation 297.5 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 3 | -433.3 microns | Standard Deviation 290.84 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 4 | -367.8 microns | Standard Deviation 305.26 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 5 | -407.0 microns | Standard Deviation 309.58 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 6 | -426.6 microns | Standard Deviation 294.63 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 7 | -421.5 microns | Standard Deviation 316.14 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 8 | -398.9 microns | Standard Deviation 299.67 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 9 | -422.1 microns | Standard Deviation 311.57 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 10 | -431.7 microns | Standard Deviation 300.95 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 11 | -438.1 microns | Standard Deviation 295.53 |
| Ranibizumab 0.5 mg | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 12 | -441.7 microns | Standard Deviation 306.53 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 11 | -417.4 microns | Standard Deviation 288.08 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 1 | -13.3 microns | Standard Deviation 207.55 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 7 | -392.7 microns | Standard Deviation 288.74 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 2 | -7.9 microns | Standard Deviation 196.65 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 10 | -395.2 microns | Standard Deviation 309.67 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 3 | -84.4 microns | Standard Deviation 274.98 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 8 | -405.2 microns | Standard Deviation 289.49 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 4 | -364.8 microns | Standard Deviation 250.48 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 12 | -416.4 microns | Standard Deviation 294.08 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 5 | -369.6 microns | Standard Deviation 273.92 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 9 | -393.5 microns | Standard Deviation 323.5 |
| Sham Injection | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | Month 6 | -372.3 microns | Standard Deviation 301.24 |
Secondary
Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
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.
Time frame: Month 1 to month 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=5 letters | 138 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=10 letters | 94 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=15 letters | 56 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=30 letters | 3 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=5 letters | 150 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=10 letters | 119 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=15 letters | 74 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=30 letters | 9 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=5 letters | 153 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=10 letters | 117 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=15 letters | 76 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=30 letters | 12 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=5 letters | 141 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=10 letters | 107 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=15 letters | 68 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=30 letters | 14 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=5 letters | 143 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=10 letters | 116 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=15 letters | 80 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=30 letters | 13 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=5 letters | 147 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=10 letters | 121 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=15 letters | 87 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=30 letters | 14 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=5 letters | 152 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=10 letters | 121 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=15 letters | 91 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=30 letters | 14 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=5 letters | 143 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=10 letters | 127 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=15 letters | 95 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=30 letters | 16 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=5 letters | 147 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=10 letters | 126 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=15 letters | 94 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=30 letters | 17 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=5 letters | 152 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=10 letters | 128 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=15 letters | 95 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=30 letters | 18 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=5 letters | 153 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=10 letters | 134 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=15 letters | 101 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=30 letters | 18 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=5 letters | 151 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=10 letters | 131 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=15 letters | 99 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=30 letters | 24 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=15 letters | 21 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=5 letters | 17 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=5 letters | 37 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=10 letters | 6 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=5 letters | 39 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=15 letters | 2 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=10 letters | 29 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=30 letters | 0 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=15 letters | 19 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=5 letters | 18 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=15 letters | 14 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=10 letters | 11 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=10 letters | 29 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=15 letters | 3 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=30 letters | 3 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=30 letters | 0 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=10 letters | 30 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=5 letters | 19 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=5 letters | 39 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=10 letters | 11 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=15 letters | 16 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=15 letters | 4 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=10 letters | 28 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=30 letters | 0 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=30 letters | 4 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=5 letters | 31 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=15 letters | 19 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=10 letters | 21 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=30 letters | 4 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=15 letters | 11 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=30 letters | 3 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=30 letters | 2 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=30 letters | 3 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=5 letters | 34 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=5 letters | 40 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=10 letters | 23 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=5 letters | 40 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=15 letters | 13 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=10 letters | 26 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=30 letters | 1 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=5 letters | 39 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=5 letters | 39 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=15 letters | 17 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=10 letters | 28 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=10 letters | 29 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=15 letters | 12 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=30 letters | 3 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=30 letters | 13 Participants |
Secondary
Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
Time frame: Month 1 to 12 months
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 1, Loss of < 15 letters | 185 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 2, Loss of < 15 letters | 182 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 3, Loss of < 15 letters | 182 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 4, Loss of < 15 letters | 179 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 5, Loss of < 15 letters | 182 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 6, Loss of < 15 letters | 180 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 7, Loss of < 15 letters | 181 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 8, Loss of < 15 letters | 177 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 9, Loss of < 15 letters | 177 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 10, Loss of < 15 letters | 180 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 11, Loss of < 15 letters | 183 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 12, Loss of < 15 letters | 182 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 11, Loss of < 15 letters | 56 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 1, Loss of < 15 letters | 57 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 7, Loss of < 15 letters | 55 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 2, Loss of < 15 letters | 53 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 10, Loss of < 15 letters | 56 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 3, Loss of < 15 letters | 51 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 8, Loss of < 15 letters | 55 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 4, Loss of < 15 letters | 55 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 12, Loss of < 15 letters | 55 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 5, Loss of < 15 letters | 56 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 9, Loss of < 15 letters | 56 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Month 6, Loss of < 15 letters | 53 Participants |
Secondary
The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline
The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.
Time frame: Month 3,6 and 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n= is the number of patients with a value for both baseline and the specific post-baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | Month 3 | 4.4 Scores on a scale | Standard Deviation 12.54 |
| Ranibizumab 0.5 mg | The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | Month 6 | 6.7 Scores on a scale | Standard Deviation 15.02 |
| Ranibizumab 0.5 mg | The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | Month 12 | 8.2 Scores on a scale | Standard Deviation 13.7 |
| Sham Injection | The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | Month 3 | 0.1 Scores on a scale | Standard Deviation 13.78 |
| Sham Injection | The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | Month 6 | 2.9 Scores on a scale | Standard Deviation 13.33 |
| Sham Injection | The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | Month 12 | 3.2 Scores on a scale | Standard Deviation 15.34 |