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- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Macugen for Histoplasmosis | |||
| Official Title ICMJE | Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Not Applicable | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: pegaptanib sodium | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Enrollment ICMJE | 24 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | May 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00272766 | |||
| Other Study ID Numbers ICMJE | 2005-0722 05-1103 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Barnes Retina Institute | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Barnes Retina Institute | |||
| Verification Date | October 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||