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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00993525

Collaborator

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

Enrollment

Arm

17.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Proliferative Diabetic Retinopathy	Drug: Intravitreal injection of ranibizumab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Mar 1, 2010

Anticipated Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravitreal anti-VEGF Intravitreal injection of 0.5 mg of ranibizumab	Drug: Intravitreal injection of ranibizumab 0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography Other Names: Lucentis

Arm

Intervention/Treatment

Experimental: Intravitreal anti-VEGF

Intravitreal injection of 0.5 mg of ranibizumab

Drug: Intravitreal injection of ranibizumab

0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography

Other Names:

Lucentis

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.