Status:
TERMINATED
Macugen for Histoplasmosis
Lead Sponsor:
Barnes Retina Institute
Collaborating Sponsors:
Pfizer
Conditions:
Ocular Histoplasmosis
Choroidal Neovascularization
Eligibility:
All Genders
18+ years
Phase:
NA
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 his...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00272766
Start Date
February 1 2006
End Date
May 1 2007
Last Update
October 27 2006
Active Locations (1)
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1
Barnes Retina Institute
St Louis, Missouri, United States, 63110