Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

Barnes Retina Institute

Status and phase: Unknown; Phase 2

Conditions: Presumed Ocular Histoplasmosis (POHS)

Treatments: Drug: ranibizumab; Drug: verteporfin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00546936

FVF4145s

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ranibizumab intravitreal injection

Experimental group

Description:

0.5 mg intravitreal injection of ranibizumab

Treatment:

Drug: ranibizumab

Photodynamic Therapy

Active Comparator group

Description:

Photodynamic therapy with Visudyne

Treatment:

Drug: verteporfin