Status:
COMPLETED
Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion
Lead Sponsor:
Peter A Campochiaro, MD
Collaborating Sponsors:
The Macula Foundation, Inc.
Genentech, Inc.
Conditions:
Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 exte...
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01198327
Start Date
August 1 2010
End Date
December 1 2012
Last Update
January 13 2014
Active Locations (6)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Retinal Consultants Medical Group
Sacremento, California, United States, 95819
3
Southeast Retina
Augusta, Georgia, United States, 30909
4
Ophthalmic consultants of Boston
Boston, Massachusetts, United States, 02114-2587