Indianapolis, Indiana 46280

  • Presumed Ocular Histoplasmosis (POHS)

Purpose:

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


Criteria:

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


NCT ID:

NCT00546936


Primary Contact:

Principal Investigator
Kevin J. Blinder, MD
Barnes Retina Institute

Ginny S Nobel, COT
Phone: 314-367-1278 ext. 2305
Email: bristudy@barnesretinainstitute.com


Backup Contact:

Email: bristudy@barnesretinainstitute.com
Carol Walters, COT
Phone: 314-367-1278 ext. 2312


Location Contact:

Indianapolis, Indiana 46280
United States

Neelam Thukral
Phone: 317-805-2152
Email: neelamt@midwest.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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