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

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ClinicalTrials.gov Identifier: NCT00993525
Recruitment Status : Unknown
Verified October 2009 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : October 12, 2009
Last Update Posted : October 12, 2009
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

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.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: Intravitreal injection of ranibizumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
Study Start Date : September 2008
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. total area of fluorescein leakage from active new vessels [ Time Frame: baseline, weeks 1,6,12,24,36,48 ]
  2. Best corrected Visual Acuity (BCVA) [ Time Frame: Baseline, weeks 1,6,12,24,36,48 ]
  3. central macular thickness [ Time Frame: baseline, weeks 1,6,12,24,36,48 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: October 12, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ranibizumab
Glucuronyl glucosamine glycan sulfate
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents