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

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

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.

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

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.
• Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
• For patients with minimally classic or occult lesions, evidence of 3 or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks and/or subretinal hemorrhage (but comprising no more than 50% of the lesion and not over the fovea).
• Clear ocular media and adequate pupillary dilation to permit good quality stereoscopic fundus photography.
• Intraocular pressure of 21 mmHg or less.
• Patients in whom PDT can be deferred for at least 54 weeks after the first study treatment (in the clinical judgment of the investigator).

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
• Significant media opacities, including cataract, that might interfere with visual acuity, assessment of toxicity or fundus photography. Patients should not be entered if it is likely that they will require cataract surgery within the following year.
• Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more, or axial length of 25 mm of more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
• Any intraocular surgery within 3 months, or extrafoveal/juxtafoveal laser within 3 months of study entry.
• Previous posterior vitrectomy, or scleral buckling surgery.
• Previous or concomitant therapy with another investigational agent to treat AMD except multivitamins or trace minerals, or treatment with an investigational agent in the past 60 days for any condition.
• Presence of pigment epithelial tears or rips.

Study Contact      1-866-Macugen 

Arizona
      Retina Centers, P.C., Northwest Location, Tucson,  Arizona,  85704,  United States; Recruiting
California
      Jules Stein Eye Institute, Los Angeles,  California,  90095,  United States; Recruiting
      Stanford University School of Medicine, Menlo Park,  California,  94025,  United States; Recruiting
Florida
      Bascom Palmer Eye Institute, Miami,  Florida,  33136,  United States; Recruiting
      Sarasota Retina Institute, Sarasota,  Florida,  34239,  United States; Recruiting
Kansas
      Vitreo-Retinal Consultants & Surgeons, P.A., Wichita,  Kansas,  67214,  United States; Recruiting
Massachusetts
      New England Eye Center, Boston,  Massachusetts,  02111,  United States; Recruiting
Michigan
      Associated Retinal Consultants, Royal Oak,  Michigan,  48073,  United States; Recruiting
Minnesota
      VitreoRetinal Surgery, P.A., Minneapolis,  Minnesota,  55435,  United States; Recruiting
New York
      Manhattan Eye, Ear & Throat, New York,  New York,  10021,  United States; Recruiting
      Long Island Vitreo-Retinal Consultants, Great Neck,  New York,  11021,  United States; Recruiting
North Carolina
      Charlotte Eye, Ear, Nose and Throat Associates, P.A., Charlotte,  North Carolina,  28210,  United States; Recruiting
      Duke University Eye Center, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      Retina Associates of Cleveland Inc., Lakewood,  Ohio,  44107,  United States; Recruiting
Oklahoma
      Dean A. McGee Eye Institute, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      The Casey Eye Institute, Portland,  Oregon,  97239,  United States; Recruiting
Pennsylvania
      Wills Eye Hospital Retina Research, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
South Carolina
      Palmetto Retina Center, Columbia,  South Carolina,  29204,  United States; Recruiting
Texas
      VitreoRetinal Consultants, Houston,  Texas,  77030,  United States; Recruiting
      Texas Retina Associates, Dallas,  Texas,  75231,  United States; Recruiting
      Valley Retina Associates, P.A., McAllen,  Texas,  78503,  United States; Recruiting
      Medical Center Ophthalmology Associates, San Antonio,  Texas,  78240,  United States; Recruiting
Washington
      University of Washington, Seattle,  Washington,  98195,  United States; Recruiting
Wisconsin
      The Eye Institute, Milwaukee,  Wisconsin,  53226,  United States; Recruiting

Study ID Numbers:  EOP 1009
Record last reviewed:  September 2004
Record first received:  July 13, 2004
ClinicalTrials.gov Identifier:  NCT00087763
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10