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

Phase 3

Completed

Conditions: Macular Edema Secondary to Branch Retinal Vein Occlusion

Interventions: Drug: Ranibizumab 0.5 mg
Other: Sham injection

Registration Number: NCT01976338

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 283

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab 0.5 mg	Ranibizumab 0.5 mg	PRN Intravitreal injection
Sham injection	Sham injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Primary Outcome Measures

Name	Time	Method
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12	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
Best Corrected Visual Acuity (BCVA) Change Over Time	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
Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time	Baseline 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	Baseline 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.
Change 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
Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time	month 3, 6 and 12	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
Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time	Months 3, 6 and 12	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
Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time	Months 3, 6 and 12	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
Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12	Baseline, months 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.