Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion

Phase 3CompletedNCT01198327

Peter A Campochiaro, MD66 enrolled

Overview

This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO \& CRUISE trials and subsequently followed in the HORIZON extension trial.

There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinal Vein Occlusion

Interventions

ranibizumabDRUG

Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.

Peripheral LaserOTHER

Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent and authorization of use and disclosure of protected health information * Age greater than or equal to 18 years * Completion of 12 months in BRAVO or CRUISE trials, with subsequent follow-up in the HORIZON extension study. Exit from HORIZON should be within 90 days of enrollment Exclusion Criteria: * Pregnancy (positive pregnancy test) or lactation * Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. * Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated. * Inability to comply with study or follow up procedures * Participation in another simultaneous medical investigation or trial

Locations (6)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Retinal Consultants Medical Group

Sacremento, California, United States

Southeast Retina

Augusta, Georgia, United States

Ophthalmic consultants of Boston

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Incidence of Serious Adverse Events.

Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.

Time frame: 24 mos

Secondary Outcomes

Mean Changes in Visual Acuity

Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.

Time frame: 24 mos from study baseline

Mean Change in Retinal Thickness

Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).

Time frame: 24 mos from study baseline

Data from ClinicalTrials.gov

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