search
Back to results

Macugen for Histoplasmosis

Primary Purpose

Ocular Histoplasmosis, Choroidal Neovascularization

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pegaptanib sodium
Sponsored by
Barnes Retina Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Histoplasmosis focused on measuring Ocular histoplasmosis, Macugen, Photodynamic therapy with Visudyne, Best-corrected visual acuity scores between 20/40-20/200, classic or occult choroidal neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of ocular histoplasmosis, Evidence of classic or occult choroidal neovascularization extending under the geometric center of the fovea, Greatest linear diameter of no greater than 5400 microns, Best-corrected visual acuity scores between 20/40-20/200, Ability to give informed consent, Limited child bearing potential and a negative pregnancy test Exclusion Criteria: Features of any condition other than OHS such as AMD, or pathologic or myopic angioid streaks associated with CNV in the study eye, Area of CNV that is less than 50% of the total lesion not including area of prior laser treatment, previous rip of retinal pigment epithelium, Vitelliform-like lesion, Telangiectasia, Central serous retinopathy, Serous pigment epithelial detachment without CNV, Any significant ocular disease other than CNV that could compromise vision in the study eye, such as amblyopia, glaucoma, optic neuropathy, or diabetic retinopathy, Inability to obtain photographs to document CNV, Presence of atrophy/scar in the center of fovea, Presence of vitreo-retinal traction over the center of the fovea, History of treatment for CNV in the study eye other than non-foveal laser photocoagulation,within 12 weeks prior to enrollment Participation in another clinical trial or use of another investigational new drug within 12 weeks of the full extent of the study treatment, Intraocular surgery within the last two months, Capsulectomy within the last month in the study eye

Sites / Locations

  • Barnes Retina Institute

Outcomes

Primary Outcome Measures

Visual function measurements, including change from baseline in visual acuity: lesion size: and leakage for one year

Secondary Outcome Measures

Patients who gain 7 or more letters or patients who lose 8 or more letters from baseline

Full Information

First Posted
January 4, 2006
Last Updated
October 25, 2006
Sponsor
Barnes Retina Institute
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00272766
Brief Title
Macugen for Histoplasmosis
Official Title
Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Terminated
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Barnes Retina Institute
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effect on visual acuity of Macugen (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary to the ocular histoplasmosis syndrome (OHS).
Detailed Description
Ocular histoplasmosis is a leading cause of severe and irreversible central vision loss in middle-aged adults living in the central and eastern US. OHS has been associated with the fungus Histoplasma capsulatum, a dimorphic soil mold found in 18 to 20 states in the central and eastern US. Annually, approximately 100,000 people are thought to be at risk of vision loss caused by OHS. This study will include OHS patients with CNV lesions no larger than 5400 microns in greatest linear diameter with classic or occult CNV extending under the geometric center of the FAZ and best-corrected visual acuity letter score between 20/40-20/200. Twenty four patients will be enrolled and the study will have 2 treatment arms with 12 patients each. The first arm will consist of 12 patients who will receive 0.3 mg of Macugen intravitreally every 6 weeks for one year. The second arm will consist of 12 patients who will receive Photodynamic Therapy (PDT) with Visudyne every 3 months for one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Histoplasmosis, Choroidal Neovascularization
Keywords
Ocular histoplasmosis, Macugen, Photodynamic therapy with Visudyne, Best-corrected visual acuity scores between 20/40-20/200, classic or occult choroidal neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium
Primary Outcome Measure Information:
Title
Visual function measurements, including change from baseline in visual acuity: lesion size: and leakage for one year
Secondary Outcome Measure Information:
Title
Patients who gain 7 or more letters or patients who lose 8 or more letters from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ocular histoplasmosis, Evidence of classic or occult choroidal neovascularization extending under the geometric center of the fovea, Greatest linear diameter of no greater than 5400 microns, Best-corrected visual acuity scores between 20/40-20/200, Ability to give informed consent, Limited child bearing potential and a negative pregnancy test Exclusion Criteria: Features of any condition other than OHS such as AMD, or pathologic or myopic angioid streaks associated with CNV in the study eye, Area of CNV that is less than 50% of the total lesion not including area of prior laser treatment, previous rip of retinal pigment epithelium, Vitelliform-like lesion, Telangiectasia, Central serous retinopathy, Serous pigment epithelial detachment without CNV, Any significant ocular disease other than CNV that could compromise vision in the study eye, such as amblyopia, glaucoma, optic neuropathy, or diabetic retinopathy, Inability to obtain photographs to document CNV, Presence of atrophy/scar in the center of fovea, Presence of vitreo-retinal traction over the center of the fovea, History of treatment for CNV in the study eye other than non-foveal laser photocoagulation,within 12 weeks prior to enrollment Participation in another clinical trial or use of another investigational new drug within 12 weeks of the full extent of the study treatment, Intraocular surgery within the last two months, Capsulectomy within the last month in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaurav K Shah, MD
Organizational Affiliation
Barnes Retina Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes Retina Institute
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Macugen for Histoplasmosis

We'll reach out to this number within 24 hrs