Macugen for Histoplasmosis

NCT00272766 | Terminated

• 2 other identifiers: 2005-072205-1103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Ocular Histoplasmosis; Choroidal Neovascularization

Keywords

Ocular histoplasmosis; Macugen; Photodynamic therapy with Visudyne; Best-corrected visual acuity scores between 20/40-20/200; classic or occult choroidal neovascularization

Outcome Measures

Primary Outcomes (1)

• Visual function measurements, including change from baseline in visual acuity: lesion size: and leakage for one year

Secondary Outcomes (1)

• Patients who gain 7 or more letters or patients who lose 8 or more letters from baseline

Interventions

pegaptanib sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barnes Retina Institute: lead
• Pfizer: collaborator

Study Sites (1)

Barnes Retina Institute

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaurav K Shah, MD

  Barnes Retina Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2006
• First Posted: January 9, 2006
• Study Start: February 1, 2006
• Study Completion: May 1, 2007
• Last Updated: October 27, 2006

Record last verified: 2006-10

Locations

US (1)