Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272766
Status:
TERMINATED
Last Update Posted:
2006-10-27
First Post:
2006-01-04
Brief Title:
Macugen for Histoplasmosis
Sponsor:
Barnes Retina Institute
Organization:
Barnes Retina Institute
Study Overview
Official Title:
Macugen for Histoplasmosis-An Open-Label Single-Site Comparative Prospective Case Series
Status:
TERMINATED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 100000 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 2040-20200 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 03 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
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 2040-20200 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 03 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-1103 | None | None | None |