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Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

Sponsor
Barnes Retina Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT00546936
Collaborator
Genentech, Inc. (Industry)
30
Enrollment
2
Locations
2
Arms
30
Duration (Months)
15
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the change in visual activity of ranibizumab to Photodynamic Therapy (PDT)in patients with choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ranibizumab vs PDT for Presumed Ocular Histoplasmosis
Study Start Date :
Oct 1, 2007
Anticipated Primary Completion Date :
Oct 1, 2009
Anticipated Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: ranibizumab intravitreal injection

0.5 mg intravitreal injection of ranibizumab

Drug: ranibizumab
0.5mg ranibizumab
Active Comparator: Photodynamic Therapy

Photodynamic therapy with Visudyne

Drug: verteporfin
Photodynamic therapy with verteporfin every 3 months for 1 year
Other Names:
  • Visudyne

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean change in visual acuity [6 months, 1 year]

    Secondary Outcome Measures

    1. To evaluate mean change in vision at 6 months [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subfoveal CNV due to presumed ocular histoplasmosis of less than 1 year duration

    • Ability to provide written informed consent and comply with study assessments for the full duration of the study

    • Age greater than or equal to 21 years of age

    • CNV lesion of than < 5400 microns in diameter

    • Best corrected visual acuity of 20/40-20/320

    • Birth control therapy for females of child-bearing potential

    Exclusion Criteria:

    • Subfoveal NCV due tp presumed ocular histoplasmosis for > 1 year

    • Pregnancy or lactation premenopausal women not using adequate contraception

    • Prior enrollment in the study

    • Any other condition that the Investigator believes would pose a significant hazard to the subject

    • Participation in another simultaneous medical investigation or trial

    • Participation in another trial or previous trial of ranibizumab or Avastin

    • Any concurrent ocular condition in the study eye (cataract, diabetic retinopathy)that could require medical or surgical intervention or ifa allowed to progress, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period

    • Previous panretinal photocoagulation

    • Previous steroids or PDT in 3 months

    • Previous participation in any studies of investigational drugs within 30 days preceding Day 0

    • Prior participation in a Genentech ranibizumab clinical trial

    • Previous treatment with intravitreally (in either eye) or intravenously administered Avastin within 3 months

    • Previous use of Macugen in the study eye within 3 months

    • Prior submacular surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Macula-Retina-Vitreous Service, Midwest Eye Institute Indianapolis Indiana United States 46280
    2 Barnes Retina Institute St. Louis Missouri United States 63110

    Sponsors and Collaborators

    • Barnes Retina Institute
    • Genentech, Inc.

    Investigators

    • Principal Investigator: Kevin J. Blinder, MD, Barnes Retina Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00546936
    Other Study ID Numbers:
    • FVF4145s
    First Posted:
    Oct 19, 2007
    Last Update Posted:
    Apr 16, 2009
    Last Verified:
    Apr 1, 2009
    Keywords provided by , ,
    Histoplasmosis
    Additional relevant MeSH terms:
    Histoplasmosis
    Ranibizumab
    Verteporfin

    Study Results

    No Results Posted as of Apr 16, 2009