To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor’s other clinical studies with this drug for AMD, until such time as the patient’s lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.

Condition	Treatment or Intervention
Macular Degeneration	Drug: pegaptanib sodium

Further Study Details: 

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.
• Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size [including blood, scar/atrophy & neovascularization] of < 12 total disc areas, of which at least 50% must be active CNV.
• Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
• Intraocular pressure of 23mmHg or less.

General Criteria:

• Patients of either gender, aged greater than 50 years.
• Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
• Written informed consent.

Exclusion Criteria:

• Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy.
• Patients who are eligible for PDT with Visudyne
• Patients who are eligible for any other of the Sponsor’s ongoing AMD studies still open to enrollment.
• Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of –8 diopters or more, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis.
• History or evidence of severe cardiac disease e.g., NYHA Functional Class III or IV (e.g. marked limitation of activity due to fatigue, alpitation or dyspnea, or worse), myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing treatment or unstable angina.
• Stroke (within 12 months of study entry)
• Acute ocular or periocular infection
• Known serious allergies to the fluorescein dye used in angiography (and indocyanine green if used) or to the components of Pegaptanib sodium formulation.

Study Contact      1-866-MACUGEN 

California
      Doheny Eye Institute, Los Angeles,  California,  90033,  United States; Recruiting
Connecticut
      Connecticut Retina Consultants, L.L.C., Bridgeport,  Connecticut,  06606,  United States; Recruiting
      New England Retina Associates, Hamden,  Connecticut,  06518,  United States; Recruiting
Florida
      Retina Health Center, Fort Myers,  Florida,  33901,  United States; Recruiting
Louisiana
      Retina Associates, New Orleans,  Louisiana,  70155,  United States; Recruiting
Maryland
      Cumberland Valley Retina Center, Hagerstown,  Maryland,  21740,  United States; Recruiting
Massachusetts
      Ophthalmic Consultants of Boston, Boston,  Massachusetts,  02114,  United States; Recruiting
      New England Eye Center, Boston,  Massachusetts,  02111,  United States; Recruiting
Michigan
      Associated Retinal Consultants, Royal Oak,  Michigan,  48073,  United States; Recruiting
Missouri
      Eye Foundation of Kansas City, Kansas City,  Missouri,  64108,  United States; Recruiting
New Hampshire
      The Eye Center of Concord, Concord,  New Hampshire,  03301,  United States; Recruiting
New Jersey
      Vitreo- Retinal Assoc. of NJ, Belleville,  New Jersey,  07109,  United States; Recruiting
      Retina Associates of New Jersey, P.A., Teaneck,  New Jersey,  07666,  United States; Recruiting
New York
      L.I. Vitreo-Retinal Consultants, Great Neck,  New York,  11021,  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
South Carolina
      Palmetto Retina Center, Columbia,  South Carolina,  29204,  United States; Recruiting
Texas
      Valley Retina Associates, P.A., McAllen,  Texas,  78503,  United States; Recruiting
Vermont
      University of Vermont College of Medicine, Burlington,  Vermont,  05401,  United States; Recruiting

Study ID Numbers:  EOP1010
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  July 21, 2004
ClinicalTrials.gov Identifier:  NCT00088192
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08