Overview

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

Status:
Unknown status

Trial end date:
2010-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Sao Paulo

Collaborators:

Fundação de Amparo à Pesquisa do Estado de São Paulo
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA)

Treatments:

Glucuronyl glucosamine glycan sulfate
Ranibizumab

Criteria

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.