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

Completed · Phase 1

Conditions studied: Age Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00446654

Run by

Progen Pharmaceuticals

People needed

43

Starts

2007-04-01

Expected to finish

2007-10-01

Last updated by the study team

2012-08-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Patients who refuse standard of care or have not benefited from standard of care in the opinion of the principal investigator.
• Clear ocular media and adequate pupillary dilatation to permit good quality ophthalmologic exam.
• Male or female patients aged >= 50 years.
• Ability to understand and the willingness to sign a written informed consent document and return for all study visits.

You may not qualify if…

• Patients with CNV not due to AMD in the study eye.
• Patients with a retinal tear in the study eye.
• Patient has a subretinal hemorrhage that comprises more than 50% of total lesion size, or has atrophy or fibrosis in the center of fovea.
• Patients who have undergone intraocular surgery within 2 months or extrafoveal/juxtafoveal laser within 3 months of study entry in the study eye.
• Any macular disease other than AMD causing vision loss in either eye.
• 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.
• Uncontrolled glaucoma (defined as intraocular pressure >25 mmHg (P0) on maximum medical therapy) or clinically significant glaucomatous visual field loss in both eyes.
• 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.
• Spherical refractive error more than -8.0 diopters in the study eye.
• Use of any approved or investigational AMD agent (standard of care) within four weeks of study enrollment.
• Use of any systemic investigational agent within 30 days of study enrollment.
• 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.
• Patients with a clinically significant or symptomatic cardiac arrhythmia, recent myocardial infarction (within 6 months), or evidence of a current significant ventricular conduction abnormality.
• Women who are pregnant or breast-feeding.
• 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.
• Allergy to fluorescein dye.

Where it is running

• Wilmer Eye Institute — Baltimore, Maryland, United States
• Dr. Quiroz-Mercado — Mexico City, District Federal, Mexico
• Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development — Cheboksary, Russia
• Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development — Moscow, Russia
• Closed Joint Stock Company "Inter YuNA" — Rostov-on-Don, Russia
• Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development — Saint Petersburg, Russia
• Saint Petersburg State Healthcare Establishment "City Consultative Diagnostic Centre #1" — Saint Petersburg, Russia
• State Educational Establishment of Higher Professional Education "Military Medical Academy named by SM Kirov" — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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