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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by University of Sao Paulo.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

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

Fundação de Amparo à Pesquisa do Estado de São Paulo

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT00993525

First received: October 9, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 9, 2009

Last Updated Date

October 9, 2009

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

total area of fluorescein leakage from active new vessels [ Time Frame: baseline, weeks 1,6,12,24,36,48 ] [ Designated as safety issue: No ]
Best corrected Visual Acuity (BCVA) [ Time Frame: Baseline, weeks 1,6,12,24,36,48 ] [ Designated as safety issue: Yes ]
central macular thickness [ Time Frame: baseline, weeks 1,6,12,24,36,48 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Proliferative Diabetic Retinopathy

Intervention ^ICMJE

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 Name: Lucentis

Study Arm (s)

Experimental: Intravitreal anti-VEGF

Intravitreal injection of 0.5 mg of ranibizumab

Intervention: Drug: Intravitreal injection of ranibizumab

Publications *

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. Epub 2012 Mar 29.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00993525

Other Study ID Numbers ^ICMJE

3003/2009

Has Data Monitoring Committee

Yes

Responsible Party

Rodrigo Sanches Oliveira, Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:

Rodrigo Jorge, MD

University of São Paulo

Information Provided By

University of Sao Paulo

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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