Choroidal Neovascularization Clinical Trial
Official title:
Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series
Verified date | October 2006 |
Source | Barnes Retina Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 24 |
Est. completion date | May 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Barnes Retina Institute | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Barnes Retina Institute | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual function measurements, including change from baseline in visual acuity: lesion size: and leakage for one year | |||
Secondary | Patients who gain 7 or more letters or patients who lose 8 or more letters from baseline |
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