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

University of Sao Paulo

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Proliferative Diabetic Retinopathy

Treatments

Drug: Intravitreal injection of ranibizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00993525

3003/2009

Details and patient eligibility

About

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.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.