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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter A Campochiaro, MD
• Collaborators: Genentech, Inc.; The Macula Foundation, Inc.
• Treatments: Ranibizumab

Criteria

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