Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.

The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a “pretend” injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).

This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a “pretend” injection. Neither the patient nor the treating ophthalmologist will know to which study injection the patient has been assigned. The ophthalmologist administering the injection will have this information.

Participation in this study will last approximately 1 year.

Condition	Treatment or Intervention	Phase
Macular Degeneration	Drug: pegaptanib sodium	Phase II

Further Study Details: 

Expected Total Enrollment:  90

This study will consist of 3 phases: a screening phase which will last up to two weeks, a confirmation phase which will last one day, and a randomization phase (the patient will be assigned by chance to a study group in this phase) which will last approximately 52 weeks. Below is a description of each phase.

Screening Phase

The screening procedures will take approximately three to four hours and will be used to determine if the patient is medically eligible for this study. These tests can be performed in one or more visits over a two-week period of time. The following procedures will take place:

- Visual acuity exam to check the patient’s vision in both eyes - Ophthalmic exam to check the front and back part of the patient’s eyes - Procedure to check the pressure in the patient’s eyes - Photos/imaging of the back of the patient’s eyes - Physical exam (not including a vaginal, rectal, or breast exam) - Blood tests for routine blood function, liver function, and kidney function - Blood test for pregnancy, only for woman of child bearing potential - Electrocardiogram (ECG), a painless test to monitor the patient’s heart rate and its rhythm - Vital sign assessments to check the patient’s blood pressure, weight, and height

If the screening evaluations indicate that the patient qualifies for the study, the patient will be asked to return to the clinic within two weeks.

Confirmation Phase

This phase will last approximately one hour and will be used to confirm the patient is still eligible for participation. The following procedure will take place:

- Photos/imaging of the back of the patient’s eye with CRVO

If the confirmation evaluations indicate the patient still qualifies for the study, the patient will immediately enter the randomization phase.

Randomization Phase

This phase will last approximately 52 weeks. The following procedures will take place approximately every 6 weeks:

- Visual acuity exam to check the patient’s vision - Ophthalmic exam to check the front and back part of the patient’s eyes - Procedure to check the pressure in the patient’s eyes - Photos/imaging of the back of the patient’s eyes - Physical exam (if the patient’s eye doctor feels it is necessary) - Blood tests for routine blood function, liver function, and kidney function - Blood tests to determine the level of medication, if any, in the blood - Vital sign assessments to check the patient’s blood pressure - Intravitreous injection of either Macugen™ or ”pretend” injection - Telephone safety call

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Ophthalmic Criteria CRVO

• CRVO must have occurred within the past 6 months and be associated with macular edema determined by OCT.
• Vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye.

General Criteria

• Patients without systemic hypertension or with stable, treated systemic hypertension are permitted to enter the study.
• Normal electrocardiogram (ECG), or clinically non-significant changes.
• Women must be using effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile.
• Adequate liver function, renal function, and blood cell counts

Exclusion Criteria:

• Presence of signs of old branch retinal vein occlusion (BRVO) or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
• Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
• Unstable glaucoma
• Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
• Patients who have received systemic, intravitreous, or subtenons’s corticosteroids for ophthalmic conditions are excluded.
• Prior treatment with an investigational agent/procedure to treat CRVO in the study eye.
• Prior treatment with investigational agents for any condition during the past 60 days for any other condition.
• Any intraocular surgery within 12 months of study entry (except cataract surgery).
• Previous posterior vitrectomy or scleral buckling surgery.
• History of retinal detachment.
• Clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction, or revascularization procedure within 6 months prior to baseline, or ventricular tachyarrythmias requiring ongoing treatment.
• History (previous surgery or amputation), or evidence (symptoms of claudication) of clinically significant peripheral vascular disease.
• Stroke within the past 12 months.
• Any major surgical procedure within one month of study entry.
• Previous radiation to the head in the region of the study eye.

Study Contact      1-866-MACUGEN 

Arizona
      Retina Centers, P.C., Northwest Location, Tucson,  Arizona,  85704,  United States; Recruiting
      Retina Associates, SW, Tucson,  Arizona,  85710,  United States; Recruiting
California
      Jules Stein Institute, Los Angeles,  California,  90095,  United States; Recruiting
      Orange County Retina Associates, Santa Ana,  California,  92705,  United States; Recruiting
Connecticut
      New England Retina Associates, Hamden,  Connecticut,  06518,  United States; Recruiting
Florida
      Retina Group of Florida, Fort Lauderdale,  Florida,  33334,  United States; Recruiting
      Bascom Palmer Eye Institute, Miami,  Florida,  33136,  United States; Recruiting
Illinois
      The University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Indiana
      Macula-Retina-Vitreous Service, Indianapolis,  Indiana,  46280,  United States; Recruiting
Kansas
      Vitreo-Retinal Consultants & Surgeons, P.A., Wichita,  Kansas,  67214,  United States; Recruiting
Louisiana
      Retina Associates, New Orleans,  Louisiana,  70155,  United States; Recruiting
Maryland
      Cumberland Valley Retina Center, Hagerstown,  Maryland,  21740,  United States; Recruiting
      Retina Group of Washington, Chevy Chase,  Maryland,  20815,  United States; Recruiting
Massachusetts
      Massachusetts Eye & Ear Infirmary, Boston,  Massachusetts,  02114,  United States; Recruiting
      New England Eye Center, Boston,  Massachusetts,  02111,  United States; Recruiting
      Lahey Clinic, The Eye Institute, Peabody,  Massachusetts,  01960,  United States; Recruiting
Michigan
      Associated Retinal Consultants, Royal Oak,  Michigan,  48073,  United States; Recruiting
      Kresge Eye Institute, Detroit,  Michigan,  48201,  United States; Recruiting
Missouri
      Eye Foundation of Kansas City, Kansas City,  Missouri,  64108,  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
      The Cleveland Clinic, Cleveland,  Ohio,  44195,  United States; Recruiting
      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
      Casey Eye Institute, Portland,  Oregon,  97239,  United States; Recruiting
Pennsylvania
      Wills Eye Institute Retina Research, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
South Carolina
      Palmetto Retina Center, Columbia,  South Carolina,  29204,  United States; Recruiting
Tennessee
      Southeastern Retina Associates, Knoxville,  Tennessee,  37909,  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
      Retina Research Institute of Texas, LLC, Abilene,  Texas,  79606,  United States; Recruiting
      Austin Retina Associates, Austin,  Texas,  78705,  United States; Recruiting
Wisconsin
      The Eye Institute, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
      University of Wisconsin, Madison,  Wisconsin,  53705,  United States; Recruiting

Study ID Numbers:  EOP 1011B
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  July 23, 2004
ClinicalTrials.gov Identifier:  NCT00088283
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08