Status:
COMPLETED
Ranibizumab Supplementing Panretinal Photocoagulation as Treatment for Iris/Angle Neovascularization in Retinal Ischemic Disease
Lead Sponsor:
Southern New England Retina Associates
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Retinal Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The object of the study is to compare treatment of iris/angle neovascularization with panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an anti-angiogenic drug: ran...
Detailed Description
A.To obtain preliminary data on the safety and tolerability of ranibizumab (0.5 mg)in patients with new or progressive neovascularization of the iris or angle due to retinal ischemic diseases in addit...
Eligibility Criteria
Inclusion
- All subjects must meet the following criteria to be eligible for study entry:
- Signed informed consent and authorization of use and disclosure of protected health information
- Age = 18 years
- Presence of iris neovascularization and or angle neovascularization due to any retinal ischemic disease that is new onset or noted to progress recently on the slit lamp examination or gonioscopy
- Best corrected visual acuity in the study eye 20/20 (Snellen equivalent using EDTRS protocol at 4 meters) to light perception. Only one eye will be enrolled in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity in the non-study eye must be better than no light perception
- Patient is able and willing to return for all scheduled visits
Exclusion
- Use of intraocular or periocular injection of steroids (for, example triamcinolone) in the study eye within 3 months of the study
- Use of intraocular injection of anti-angiogenic drugs in the study eye and or participation in a clinical trial using an antiangiogenic treatment within 45 days from the enrollment in the study.
- Acute endophthalmitis within 1 month.
- Recent rhegmatogenous retinal detachment or macular hole surgery within last 2 months
- Uncontrolled uveitis in the last month.
- Treatment with PRP within 2 weeks of the study enrollment.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00841373
Start Date
July 1 2007
End Date
January 1 2010
Last Update
November 19 2014
Active Locations (1)
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1
Southern New England Retina Associates
Providence, Rhode Island, United States, 02904