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

October 9, 2009
October 9, 2009
September 2008
March 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study)
INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Proliferative Diabetic Retinopathy
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
Experimental: Intravitreal anti-VEGF
Intravitreal injection of 0.5 mg of ranibizumab
Intervention: Drug: Intravitreal injection of ranibizumab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00993525
3003/2009
Yes
Rodrigo Sanches Oliveira, Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
University of Sao Paulo
  • Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA)
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Chair: Rodrigo Jorge, MD University of São Paulo
University of Sao Paulo
October 2009

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