Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion
Completed · Phase 3
Conditions studied: Retinal Vein Occlusion
In brief
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.
Key facts
- Study ID
- NCT01198327
- Run by
- Peter A Campochiaro, MD
- People needed
- 66
- Starts
- 2010-08-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2014-01-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Retina Associates of New Jersey — Teaneck, New Jersey, United States
- Retina Consultants of Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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