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

Phase 1

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: CGC-11047

• Registration Number: NCT00446654
• Lead Sponsor: Progen Pharmaceuticals

Brief 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.

Detailed Description

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. Half of the participants in the study will receive CGC-11047 every two weeks and half of the participants in the study will receive CGC-11047 every four weeks. If your doctor determines that you are eligible for the study based on his/her judgement and according to the entry requirements set by the sponsor of the research, you will be randomly assigned (by chance, like the flip of a coin), to receive CGC-11047 every two weeks or every four weeks. Whether you receive drug every two weeks or every four weeks, you will still need to come to the clinic approximately every two weeks for the first three months, and approximately four times after that until it has been at least 12 months since you received your first treatment of study drug.

Two studies (this one and another one) are occurring to test CGC-11047 in patients with wet age-related macular degeneration for the first time. However, this drug (CGC-11047) is being studied in cancer patients at doses much higher than will be given to any subjects in either of these studies. The cancer patients have tolerated the drug well with the exception of one cancer patient who had two reactions to the drug (pancreatitis and hypotension). However, this patient had advanced cancer (non-Hodgkin's lymphoma with a life expectancy of less than 3 months) and received 38X the dose to be administered in this AMD study. Aside from this one patient, there have not been any serious side effects related to the drug.

This study will involve about 100 subjects at about 15 different sites internationally.

The study will take place over 12 months and will include about 12 office visits to the study doctor.

Study Timeline

• Study First Submitted: 2007-03-09
• Study First Submitted QC: 2007-03-09
• Study First Posted: 2007-03-13
• Study Start: 2007-04
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2012-05-29
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-28
• Last Update Submitted: 2012-06-28
• Results First Posted: 2012-08-06
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGC-11047 once every 2 weeks	CGC-11047	16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
CGC-11047 once every four weeks	CGC-11047	16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.

Primary Outcome Measures

Name	Time	Method
Change in Baseline to 3 Months in Best Corrected Visual Acuity	Baseline and 3 months	Visual acuity was measured with a standard eye exam using the preferred research based eye chart (LogMar chart). On the LogMar chart each letter has a score value of 0.02 log units. LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of letters read).; The outcome measure presented is the difference in LogMAR between baseline and at three months.

Secondary Outcome Measures

Name	Time	Method
Safety of 2-weekly or 4-weekly Administration of CGC-11047	3 months
To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization	3 months

Trial Locations

Locations (6)

Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States

Closed Joint Stock Company "Inter YuNA"; 🇷🇺 Rostov-on-Don, Russian Federation

Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development; 🇷🇺 St Petersburg, Russian Federation

State Educational Establishment of Higher Professional Education "Military Medical Academy named by SM Kirov"; 🇷🇺 St Petersburg, Russian Federation

Dr. Quiroz-Mercado; 🇲🇽 Mexico City, District Federal, Mexico

Saint Petersburg State Healthcare Establishment "City Consultative Diagnostic Centre #1"; 🇷🇺 St Petersburg, Russian Federation