Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546936
Recruitment Status : Unknown
Verified April 2009 by Barnes Retina Institute.
Recruitment status was:  Recruiting
First Posted : October 19, 2007
Last Update Posted : April 16, 2009
Genentech, Inc.
Information provided by:
Barnes Retina Institute

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
Presumed Ocular Histoplasmosis (POHS) Drug: ranibizumab Drug: verteporfin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2007
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Histoplasmosis
U.S. FDA Resources

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 Name: Visudyne

Primary Outcome Measures :
  1. Mean change in visual acuity [ Time Frame: 6 months, 1 year ]

Secondary Outcome Measures :
  1. To evaluate mean change in vision at 6 months [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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

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 identifier (NCT number): NCT00546936

Contact: Ginny S Nobel, COT 314-367-1278 ext 2305
Contact: Carol Walters, COT 314-367-1278 ext 2312

United States, Indiana
Macula-Retina-Vitreous Service, Midwest Eye Institute Recruiting
Indianapolis, Indiana, United States, 46280
Contact: Neelam Thukral    317-805-2152   
Principal Investigator: Thomas Ciulla, MD         
United States, Missouri
Barnes Retina Institute Recruiting
St. Louis, Missouri, United States, 63110
Contact: Ginny S Nobel, COT    314-367-1278 ext 2305   
Contact: Carol L Walters, COT    314-367-2287 ext 2312   
Principal Investigator: Kevin J Blinder, MD         
Sponsors and Collaborators
Barnes Retina Institute
Genentech, Inc.
Principal Investigator: Kevin J. Blinder, MD Barnes Retina Institute

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kevin Blinder, MD, Barnes Retina Institute Identifier: NCT00546936     History of Changes
Other Study ID Numbers: FVF4145s
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: April 16, 2009
Last Verified: April 2009

Keywords provided by Barnes Retina Institute:

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents