Macugen for Histoplasmosis

NCT00272766

Last updated date
Study Location
Barnes Retina Institute
St. Louis, Missouri, 63110, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ocular Histoplasmosis, Choroidal Neovascularization
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Ocular Histoplasmosis, Choroidal NeovascularizationMacugen for Histoplasmosis
NCT00272766
  1. St. Louis, Missouri
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Ocular Histoplasmosis
  • Choroidal Neovascularization
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
 (submitted: January 5, 2006)
24
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Gaurav K Shah, MDBarnes Retina Institute
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