Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

Phase 2

• Conditions: Presumed Ocular Histoplasmosis (POHS)
• Interventions: Drug: ranibizumab; Drug: verteporfin

• Registration Number: NCT00546936
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-15
• Last Update Posted: 2009-04-16
• Primary Completion: 2009-10
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ranibizumab intravitreal injection	ranibizumab	0.5 mg intravitreal injection of ranibizumab
Photodynamic Therapy	verteporfin	Photodynamic therapy with Visudyne

Primary Outcome Measures

Name	Time	Method
Mean change in visual acuity	6 months, 1 year

Secondary Outcome Measures

Name	Time	Method
To evaluate mean change in vision at 6 months	6 months

Trial Locations

Locations (2)

Barnes Retina Institute; 🇺🇸 St. Louis, Missouri, United States

Macula-Retina-Vitreous Service, Midwest Eye Institute; 🇺🇸 Indianapolis, Indiana, United States