Safety of 16.5 mg (3.3%) CGC-11047 Once Every 2 Weeks vs. Once Every 4 Weeks in Patients With CNV Due to AMD
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: CGC-11047
Intervention description: 16.5 mg (3.3%) subconjunctival injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to determine how safe and effective subconjunctival
      injections of CGC-11047 are in subjects with wet age related macular degeneration at two
      different dosing intervals.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a diagnosis of subfoveal choroidal neovascularization secondary to AMD
             in the study eye, with leaking present on a fluorescein angiogram as determined by the
             clinical investigator.

          2. Visual acuity: BCVA in the study eye between 20/40 and 20/320 and better than or equal
             to 20/320 in the fellow eye.

          3. Patients who refuse standard of care or have not benefited from standard of care in
             the opinion of the principal investigator.

          4. Clear ocular media and adequate pupillary dilatation to permit good quality
             ophthalmologic exam.

          5. Male or female patients aged >= 50 years.

          6. Ability to understand and the willingness to sign a written informed consent document
             and return for all study visits.

        Exclusion Criteria:

          1. Patients with CNV not due to AMD in the study eye.

          2. Patients with a retinal tear in the study eye.

          3. Patient has a subretinal hemorrhage that comprises more than 50% of total lesion size,
             or has atrophy or fibrosis in the center of fovea.

          4. Patients who have undergone intraocular surgery within 2 months or
             extrafoveal/juxtafoveal laser within 3 months of study entry in the study eye.

          5. Any macular disease other than AMD causing vision loss in either eye.

          6. Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either
             eye. Anterior segment diseases such as blepharitis, ocular rosacea, lid problems which
             could increase the risk of infection after study drug injection.

          7. Uncontrolled glaucoma (defined as intraocular pressure >25 mmHg (P0) on maximum
             medical therapy) or clinically significant glaucomatous visual field loss in both
             eyes.

          8. Significant media opacities, including cataract that might interfere with visual
             acuity, assessment of toxicities or fundus photography in the study eye in the
             judgement of the clinical investigator.

          9. Spherical refractive error more than -8.0 diopters in the study eye.

         10. Use of any approved or investigational AMD agent (standard of care) within four weeks
             of study enrollment.

         11. Use of any systemic investigational agent within 30 days of study enrollment.

         12. Any uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.

         13. Patients with a clinically significant or symptomatic cardiac arrhythmia, recent
             myocardial infarction (within 6 months), or evidence of a current significant
             ventricular conduction abnormality.

         14. Women who are pregnant or breast-feeding.

         15. Women of childbearing potential and male patients who are partners of women of
             childbearing potential who are unwilling to use approved, effective means of
             contraception according to the institution's standards.

         16. Allergy to fluorescein dye.