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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extended Follow-up of Patients With Macular Edema Due to bRanch rETinal Vein Occlusion (BRVO) or centrAl Retinal veIn occlusioN (CRVO) Previously Treated With Intravitreal Ranibizumab

Conditions
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Retinal Vein Occlusion

Intervention / Treatment
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* Drug: ranibizumab
* Other: Peripheral Laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab as needed<br>Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion. | Drug: ranibizumab<br>* Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.<br>* Other names: RBZ, lucentis;Other: Peripheral Laser<br>* Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.<br>* Other names: Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Events. | Record the serious adverse events, both ocular and non-ocular to gather long-term safety data. | 24 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 mos from study baseline | 
| Mean Change in Retinal Thickness | Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography). | 24 mos from study baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RVO, CRVO, BRVO, Horizon, Bravo, Cruise