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

October 17, 2007
October 19, 2007
April 16, 2009
October 2007
October 2009   (Final data collection date for primary outcome measure)
Mean change in visual acuity [ Time Frame: 6 months, 1 year ]
Mean change in visual acuity on the ETDRS chart at 4 meters of ranibizumab patients vs PDT patients from baseline to 1 year [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00546936 on Archive Site
To evaluate mean change in vision at 6 months [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis
Ranibizumab vs PDT for Presumed Ocular Histoplasmosis
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
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Presumed Ocular Histoplasmosis (POHS)
  • Drug: ranibizumab
    0.5mg ranibizumab
  • Drug: verteporfin
    Photodynamic therapy with verteporfin every 3 months for 1 year
    Other Name: Visudyne
  • Experimental: ranibizumab intravitreal injection
    0.5 mg intravitreal injection of ranibizumab
    Intervention: Drug: ranibizumab
  • Active Comparator: Photodynamic Therapy
    Photodynamic therapy with Visudyne
    Intervention: Drug: verteporfin
Ramaiya KJ, Blinder KJ, Ciulla T, Cooper B, Shah GK. Ranibizumab versus photodynamic therapy for presumed ocular histoplasmosis syndrome. Ophthalmic Surg Lasers Imaging Retina. 2013 Jan-Feb;44(1):17-21. doi: 10.3928/23258160-20121221-07.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
April 2010
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Kevin Blinder, MD, Barnes Retina Institute
Barnes Retina Institute
Genentech, Inc.
Principal Investigator: Kevin J. Blinder, MD Barnes Retina Institute
Barnes Retina Institute
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP