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

NCT ID: NCT00993525

Last Updated: 2009-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-03-31

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.

Conditions

Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravitreal anti-VEGF

Intravitreal injection of 0.5 mg of ranibizumab

Group Type: EXPERIMENTAL

Intravitreal injection of ranibizumab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Lucentis

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA)

UNKNOWN

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Principal Investigators

Rodrigo Jorge, MD

Role: STUDY_CHAIR

University of Sao Paulo

References

Messias A, Ramos Filho JA, Messias K, Almeida FP, Costa RA, Scott IU, Gekeler F, Jorge R. Electroretinographic findings associated with panretinal photocoagulation (PRP) versus PRP plus intravitreal ranibizumab treatment for high-risk proliferative diabetic retinopathy. Doc Ophthalmol. 2012 Jun;124(3):225-36. doi: 10.1007/s10633-012-9322-5. Epub 2012 Mar 29.

Reference Type: DERIVED

PMID: 22457045 (View on PubMed)

Other Identifiers

3003/2009

Identifier Type: -

Identifier Source: org_study_id