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Macugen for Histoplasmosis

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT00272766
First received: January 4, 2006
Last updated: October 25, 2006
Last verified: October 2006
History of Changes
  Purpose

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).


Condition Intervention
Ocular Histoplasmosis
Choroidal Neovascularization
 Drug: pegaptanib sodium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series

Resource links provided by NLM:

MedlinePlus related topics: Histoplasmosis
U.S. FDA Resources

Further study details as provided by Barnes Retina Institute:

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

Estimated Enrollment: 24
Study Start Date: February 2006
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272766

Locations
United States, Missouri
Barnes Retina Institute
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Barnes Retina Institute
Pfizer
Investigators
Principal Investigator: Gaurav K Shah, MD Barnes Retina Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00272766     History of Changes
Other Study ID Numbers: 2005-0722, 05-1103
Study First Received: January 4, 2006
Last Updated: October 25, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Barnes Retina Institute:
Ocular histoplasmosis
Macugen
Photodynamic therapy with Visudyne
Best-corrected visual acuity scores between 20/40-20/200
classic or occult choroidal neovascularization

Additional relevant MeSH terms:
Histoplasmosis
Neovascularization, Pathologic
Choroidal Neovascularization
Mycoses
Metaplasia
 Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013