Macugen for Histoplasmosis - Full Text View

Sponsors and Collaborators:	Barnes Retina Institute Pfizer
Information provided by:	Barnes Retina Institute
ClinicalTrials.gov Identifier:	NCT00272766

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:	Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series

Resource links provided by NLM:

Drug Information available for: Pegaptanib sodium

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

Study ID Numbers:	2005-0722, 05-1103
Study First Received:	January 4, 2006
Last Updated:	October 25, 2006
ClinicalTrials.gov Identifier:	NCT00272766 History of Changes
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

Study placed in the following topic categories:

Mycoses
Uveal Diseases
Eye Diseases
Metaplasia
Choroid Diseases

Histoplasmosis
Verteporfin
Neovascularization, Pathologic
Choroidal Neovascularization

Additional relevant MeSH terms:

Mycoses
Uveal Diseases
Pathologic Processes
Eye Diseases
Metaplasia

Choroid Diseases
Histoplasmosis
Neovascularization, Pathologic
Choroidal Neovascularization

ClinicalTrials.gov processed this record on September 01, 2009