search
Back to results

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

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Intravitreal injection of ranibizumab
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring diabetic retinopathy, ranibizumab, new vessels, intravitreal injection, Persistent retina new vessels

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intravitreal anti-VEGF

    Arm Description

    Intravitreal injection of 0.5 mg of ranibizumab

    Outcomes

    Primary Outcome Measures

    total area of fluorescein leakage from active new vessels
    Best corrected Visual Acuity (BCVA)
    central macular thickness

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2009
    Last Updated
    October 9, 2009
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA), Fundação de Amparo à Pesquisa do Estado de São Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00993525
    Brief Title
    Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study)
    Acronym
    INIPE
    Official Title
    INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    March 2010 (Anticipated)
    Study Completion Date
    March 2010 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proliferative Diabetic Retinopathy
    Keywords
    diabetic retinopathy, ranibizumab, new vessels, intravitreal injection, Persistent retina new vessels

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravitreal anti-VEGF
    Arm Type
    Experimental
    Arm Description
    Intravitreal injection of 0.5 mg of ranibizumab
    Intervention Type
    Drug
    Intervention Name(s)
    Intravitreal injection of ranibizumab
    Other Intervention Name(s)
    Lucentis
    Intervention Description
    0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography
    Primary Outcome Measure Information:
    Title
    total area of fluorescein leakage from active new vessels
    Time Frame
    baseline, weeks 1,6,12,24,36,48
    Title
    Best corrected Visual Acuity (BCVA)
    Time Frame
    Baseline, weeks 1,6,12,24,36,48
    Title
    central macular thickness
    Time Frame
    baseline, weeks 1,6,12,24,36,48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rodrigo Jorge, MD
    Organizational Affiliation
    University of São Paulo
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22457045
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs