Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-12

Study Completion Date

2016-03-14

Brief Summary

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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

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Detailed Description

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Conditions

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Central 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

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

Sham injection

As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type OTHER

Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.

Interventions

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Sham injection

Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.

Intervention Type OTHER

Ranibizumab 0.5 mg

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

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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Inclusion Criteria

• 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No