Status:
UNKNOWN
Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study)
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA)
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Proliferative Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.
Eligibility Criteria
Inclusion
- persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior;
- logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse.
Exclusion
- history of vitrectomy in the study eye;
- history of thromboembolic event (including myocardial infarction or cerebral vascular accident);
- major surgery within the prior 6 months or planned within the next 28 days;
- uncontrolled hypertension;
- known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00993525
Start Date
September 1 2008
End Date
March 1 2010
Last Update
October 12 2009
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