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

Peter A Campochiaro, MD

Status and phase: Completed; Phase 3

Conditions: Retinal Vein Occlusion

Treatments: Drug: ranibizumab; Other: Peripheral Laser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01198327

NA_00040287

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Ranibizumab as needed

Experimental group

Description:

Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.

Treatment:

Other: Peripheral Laser

Drug: ranibizumab