Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)

This study has been completed.

Sponsors and Collaborators:	Eyetech Pharmaceuticals Pfizer
Information provided by:	Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00087763

Purpose

The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in patients with wet AMD.

Condition	Intervention	Phase
Macular Degeneration	Drug: Macugen ™ (pegaptanib sodium injection)	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Dietary Sodium Macular Degeneration

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Phase II Prospective, Randomized, Double-Masked, Sham-Controlled, Dose-Ranging, Multi-Center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)

Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment:	135
Study Start Date:	March 2004
Estimated Study Completion Date:	May 2006

Detailed Description:

This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center and foveal thickness to be treated either Macugen or a sham injection. After 24 weeks, all patients will treated with Macugen until the end of the study at 54 weeks.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.
Foveal thickness <= 300 um (measured by OCT center point thickness).
Subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy & neovascularization) of <= 12 disc areas, of which at least 50% must be active CNV.

Exclusion Criteria:

Previous subfoveal thermal laser therapy.
Any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. Additionally no more than 25% of the total lesion size may be made up of scarring or atrophy.
Previous photodynamic therapy with Visudyne (PDT) in the study eye. Eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, PDT can be deferred for at least 54 weeks after the first study treatment

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	EOP 1009
Study First Received:	July 13, 2004
Last Updated:	May 2, 2006
ClinicalTrials.gov Identifier:	NCT00087763
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eyetech Pharmaceuticals:

AMD
Age Related Macular Degeneration
Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic

Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

ClinicalTrials.gov processed this record on January 15, 2009