Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Barnes Retina Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT00546936
First received: October 17, 2007
Last updated: April 15, 2009
Last verified: April 2009

October 17, 2007
April 15, 2009
October 2007
October 2009   (final data collection date for primary outcome measure)
Mean change in visual acuity [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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
Both
21 Years and older
No
Contact: Ginny S Nobel, COT 314-367-1278 ext 2305 bristudy@barnesretinainstitute.com
Contact: Carol Walters, COT 314-367-1278 ext 2312 bristudy@barnesretinainstitute.com
United States
 
NCT00546936
FVF4145s
Yes
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