Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study)

Sponsor: University of Sao Paulo
Study ID: NCT00993525
Phase: PHASE1/PHASE2
Status: Unknown

Conditions

Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Intravitreal injection of ranibizumab — DRUG
0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography

Study Details

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.

Key Dates

First listed: Oct 12, 2009
Start date: Sep 30, 2008
Status verified: Oct 2009
Primary completion: Mar 31, 2010
Completion: Mar 31, 2010

Study Design

Enrollment: 22 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Intravitreal anti-VEGF
Intravitreal injection of 0.5 mg of ranibizumab

Primary Outcome Measure

total area of fluorescein leakage from active new vessels [ Time Frame: baseline, weeks 1,6,12,24,36,48 ]