Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium
Condition: Age-Related Macular Degeneration; Retinal Vein Occlusion; Diabetic Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Retinal Vein Occlusion
Intervention: pegaptanib sodium injection
Intervention description: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study was conducted because the FDA requested clinical information on potential effects
      of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal
      endothelium from a 1-year (minimum) post-approval clinical study to support that there are no
      adverse effects on the corneal endothelium following intravitreal injections of Macugen.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of either gender aged > or = to 50 years diagnosed with subfoveal neovascular
             Age-Related Macular Degeneration, Diabetic Macular Edema, or Retinal Vein Occlusion.

          2. Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or
             between 20/20 and 20/400 using a Snellen chart.

          3. Women must be using two forms of effective contraception, be post-menopausal for at
             least 12 months prior to study entry, or surgically sterile; if of child-bearing
             potential, a urine pregnancy test must be performed within 7 days prior to the first
             injection with a negative result. If the test is positive, a serum test must be done
             to confirm. 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.

          4. Provide written informed consent.

          5. Ability to return for all study visits.

        Exclusion Criteria:

        Subjects will not be eligible for the study if subjects cannot attend all study-required
        visits, or if any of the following criteria are present

          1. Unilateral ocular blunt trauma within one year of enrollment and no greater than 5%
             difference in central endothelial cell density between the 2 eyes.

          2. intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or
             mini-shunt) within one year of enrollment.

          3. Anterior segment laser surgery (laser trabeculoplasty) performed within one year of
             enrollment.

          4. Glaucoma tube-shunt surgery

          5. Previous history of corneal transplant in the study or non-study eye

          6. Presence of vitreous macular traction

          7. Previous therapeutic radiation in the region of the study eye

          8. Any treatment with an investigational agent in the past 30 days for any condition

          9. Known serious allergies to the components of pegaptanib sodium formulation

        Any of the following underlying diseases including:1. History or evidence of severe cardiac
        disease(e.g. NYHA Functional Class III or IV - see Appendix 2), clinical or medical history
        of unstable angina, acute coronary syndrome, myocardial infarction or revascularization
        within 6 months, ventricular tachyarrhythmias requiring ongoing treatment 7. History or
        evidence of clinically significant peripheral vascular disease, such as intermittent
        claudication or prior amputation 8. History or evidence of clinically significant impaired
        renal or hepatic function 8. Stroke (within 12 months of study entry) 9. Any major surgical
        procedure within one month of study entry 10. Significant media opacities, including
        cataract, which might interfere with visual acuity, assessment of toxicity. Subjects should
        not be entered if there is likelihood that they will require cataract or glaucoma surgery
        in either eye during the study treatment and follow-up period.