Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)

Study Overview
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Brief Summary
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Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO

Official Title
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A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Branch Retinal Vein Occlusion (BRVO) [Blossom]

Conditions
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Macular Edema Secondary to Branch Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Ranibizumab 0.5 mg
* Other: Sham injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 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 without 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 few months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab 0.5 mg<br>PRN Intravitreal injection | Drug: Ranibizumab 0.5 mg<br>* intravitreal injection of 0.05 ml<br>|
| Sham Comparator: Sham injection<br>As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection | Other: Sham injection<br>* Sham intravitreal injection<br>* Other names: Sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 | 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 6 and compared to Baseline. | Baseline to Month 1 through Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change of Best Corrected Visual Acuity (BCVA) in Patients 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 | Baseline to Month 1 through Month 12 | 
| Best Corrected Visual Acuity (BCVA) Change 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. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline | Month 1 through Month 12 | 
| 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 | Baseline to month 12 | 
| Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | 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. | Baseline to 12 months | 
| Change 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 | Month 1 to month 12 | 
| Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time | Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes | month 3, 6 and 12 | 
| Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time | Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes | Months 3, 6 and 12 | 
| Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time | Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes | Months 3, 6 and 12 | 
| Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 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. | Baseline, months 3, 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab, branch retinal vein occlusion, anti-VEGF therapy, RFB002