This trial is active, not recruiting.

Condition proliferative diabetic retinopathy
Treatment intravitreal injection of ranibizumab
Phase phase 1/phase 2
Sponsor University of Sao Paulo
Collaborator Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA)
Start date September 2008
End date March 2010
Trial size 22 participants
Trial identifier NCT00993525, 3003/2009


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Intravitreal injection of 0.5 mg of ranibizumab
intravitreal injection of ranibizumab Lucentis
0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography

Primary Outcomes

total area of fluorescein leakage from active new vessels
time frame: baseline, weeks 1,6,12,24,36,48
Best corrected Visual Acuity (BCVA)
time frame: Baseline, weeks 1,6,12,24,36,48
central macular thickness
time frame: baseline, weeks 1,6,12,24,36,48

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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.

Additional Information

Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by University of Sao Paulo.