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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
  Purpose

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 Intervention Phase
Proliferative Diabetic Retinopathy
 Drug: Intravitreal injection of ranibizumab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 22
Study Start Date: September 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lucentis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993525

Sponsors and Collaborators
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
Investigators
Study Chair: Rodrigo Jorge, MD University of São Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rodrigo Sanches Oliveira, Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00993525     History of Changes
Other Study ID Numbers: 3003/2009
Study First Received: October 9, 2009
Last Updated: October 9, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
diabetic retinopathy
ranibizumab
new vessels
intravitreal injection
Persistent retina new vessels

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013