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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Progen Pharmaceuticals

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.