Macugen for Histoplasmosis

Choroidal Neovascularization Clinical Trial

Official title:

Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00272766
• Other study ID #: 2005-0722
• Secondary ID: 05-1103
• Status: Terminated
• Phase: N/A
• First received: January 4, 2006
• Last updated: October 25, 2006
• Start date: February 2006
• Est. completion date: May 2007

Study information

• 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

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 2007
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Histoplasmosis
• Neovascularization, Pathologic
• Ocular Histoplasmosis

Intervention

Drug:
• pegaptanib sodium

Locations

Country	Name	City	State
United States	Barnes Retina Institute	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Barnes Retina Institute	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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