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Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks

Primary Purpose

Angioid Streaks

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioid Streaks focused on measuring angioid streaks, CNV, intra vitreal ranibizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Angioid streaks
  • Subfoveal CNV of recent onset with the following characteristics
  • Absence of subfoveal fibrosis
  • Fibrosis less than 25% of the lesion
  • Presence of blood, subretinal fluid, and/or lipid
  • New onset symptoms within 12 weeks
  • Visual acuity 20/40 to 20/800 on an ETDRS chart

Exclusion Criteria:

  • Prior treatment of subfoveal CNV in the study eye
  • Age-related macular degeneration
  • Uncontrolled glaucoma
  • High myopia (> -10.00 D spherical equivalent)
  • Prior retinal detachment
  • Media opacity preventing adequate view of the retina
  • Planned cataract surgery in the next 3 months
  • Current chemotherapy for cancer
  • Immunocompromised state
  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • History of any previous treatment for angioid streaks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ranibizumab

    Arm Description

    Outcomes

    Primary Outcome Measures

    The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)

    Secondary Outcome Measures

    Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12

    Full Information

    First Posted
    November 17, 2009
    Last Updated
    June 28, 2012
    Sponsor
    University of Illinois at Chicago
    Collaborators
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01015495
    Brief Title
    Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks
    Official Title
    Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not enough patients within the time frame to allow for a meaningful study.
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    December 2010 (Anticipated)
    Study Completion Date
    January 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago
    Collaborators
    Genentech, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.
    Detailed Description
    Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Angioid Streaks
    Keywords
    angioid streaks, CNV, intra vitreal ranibizumab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ranibizumab
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    ranibizumab
    Other Intervention Name(s)
    Lucentis
    Intervention Description
    0.5 mg dose of ranibizumab. Treatment will be given at baseline, month 1, and month 2, and then monthly until OCT shows absence of subretinal fluid and FA shows absence of leakage
    Primary Outcome Measure Information:
    Title
    The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
    Time Frame
    Month 12
    Secondary Outcome Measure Information:
    Title
    Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12
    Time Frame
    Month 6 and 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 18 years Angioid streaks Subfoveal CNV of recent onset with the following characteristics Absence of subfoveal fibrosis Fibrosis less than 25% of the lesion Presence of blood, subretinal fluid, and/or lipid New onset symptoms within 12 weeks Visual acuity 20/40 to 20/800 on an ETDRS chart Exclusion Criteria: Prior treatment of subfoveal CNV in the study eye Age-related macular degeneration Uncontrolled glaucoma High myopia (> -10.00 D spherical equivalent) Prior retinal detachment Media opacity preventing adequate view of the retina Planned cataract surgery in the next 3 months Current chemotherapy for cancer Immunocompromised state Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Participation in another simultaneous medical investigation or trial History of any previous treatment for angioid streaks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer I Lim, MD
    Organizational Affiliation
    UIC Eye and Ear Infirmary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.uic.edu/com/eye/
    Description
    UIC-Ophthalmology home page

    Learn more about this trial

    Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks

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