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

Proliferative Diabetic Retinopathy Clinical Trial

— INIPE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00993525
• Other study ID #: 3003/2009
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: October 9, 2009
• Last updated: October 9, 2009
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: October 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo, Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total area of fluorescein leakage from active new vessels		baseline, weeks 1,6,12,24,36,48	No
Primary	Best corrected Visual Acuity (BCVA)		Baseline, weeks 1,6,12,24,36,48	Yes
Primary	central macular thickness		baseline, weeks 1,6,12,24,36,48	No