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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-12

Study Completion Date

2016-03-28

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

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Detailed Description

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Conditions

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Macular Edema Secondary to Branch Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ranibizumab 0.5 mg

PRN Intravitreal injection

Group Type EXPERIMENTAL

Ranibizumab 0.5 mg

Intervention Type DRUG

intravitreal injection of 0.05 ml

Sham injection

As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type OTHER

Sham intravitreal injection

Interventions

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Ranibizumab 0.5 mg

intravitreal injection of 0.05 ml

Intervention Type DRUG

Sham injection

Sham intravitreal injection

Intervention Type OTHER

Other Intervention Names

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Sham

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No