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]

Novartis Pharmaceuticals1 site in 1 country283 target enrollmentNovember 12, 2013

ConditionsMacular Edema Secondary to Branch Retinal Vein Occlusion

InterventionsRanibizumab 0.5 mg Sham injection

DrugsRanibizumab 0.5 mg

Overview

Phase: Phase 3
Intervention: Ranibizumab 0.5 mg
Conditions: Macular Edema Secondary to Branch Retinal Vein Occlusion
Sponsor: Novartis Pharmaceuticals
Enrollment: 283
Locations: 1
Primary Endpoint: Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 12, 2013

End Date

March 28, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Ranibizumab 0.5 mg

PRN Intravitreal injection

Intervention: Ranibizumab 0.5 mg

Sham injection

As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Intervention: Sham injection

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

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) Change Over Time(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(Baseline to month 12)
Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye(Baseline to 12 months)
Change in Central-Sub-Field- Thickness (CSFT) Over Time(Month 1 to month 12)
Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time(month 3, 6 and 12)
Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time(Months 3, 6 and 12)
Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time(Months 3, 6 and 12)
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)