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

Phase 3

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ranibizumab as needed	ranibizumab	Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.
Ranibizumab as needed	Peripheral Laser	Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events.	24 mos	Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.

Secondary Outcome Measures

Name	Time	Method
Mean Changes in Visual Acuity	24 mos from study baseline	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.
Mean Change in Retinal Thickness	24 mos from study baseline	Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).

Locations (6): Retina Consultants of Houston
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Houston, Texas, United States
Retina-Vitreous Associates Medical Group
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Beverly Hills, California, United States
Retinal Consultants Medical Group
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Sacremento, California, United States
Southeast Retina
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Augusta,, Georgia, United States
Retina Associates of New Jersey
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Teaneck, New Jersey, United States
Ophthalmic consultants of Boston
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Boston, Massachusetts, United States