Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

April 15, 2009 updated by: Barnes Retina Institute

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Recruiting
        • Macula-Retina-Vitreous Service, Midwest Eye Institute
        • Contact:
        • Principal Investigator:
          • Thomas Ciulla, MD
    • Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ranibizumab intravitreal injection
0.5 mg intravitreal injection of ranibizumab
Drug: ranibizumab
0.5mg ranibizumab
ACTIVE_COMPARATOR: Photodynamic Therapy
Photodynamic therapy with Visudyne
Drug: verteporfin
Photodynamic therapy with verteporfin every 3 months for 1 year
Other Names:
  • Visudyne

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in visual acuity
Time Frame: 6 months, 1 year
6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate mean change in vision at 6 months
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barnes Retina Institute

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Kevin J. Blinder, MD, Barnes Retina Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ANTICIPATED)

October 1, 2009

Study Completion (ANTICIPATED)

April 1, 2010

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (ESTIMATE)

October 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2009

Last Update Submitted That Met QC Criteria

April 15, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVF4145s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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