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

NCT00446654 | Completed Phase 1 Results

• 1 other identifier: 47-MD-002
• Study Type: interventional
• Target: 43
• Locations: 3 countries
• Sites: 8

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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change in Baseline to 3 Months in Best Corrected Visual Acuity

  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.

  Baseline and 3 months

Secondary Outcomes (2)

• 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

Study Arms (2)

CGC-11047 once every 2 weeks

EXPERIMENTAL

16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.

Drug: CGC-11047

CGC-11047 once every four weeks

EXPERIMENTAL

16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.

Drug: CGC-11047

Interventions

CGC-11047 DRUG

16.5 mg (3.3%) subconjunctival injection

Also known as: PG11047

CGC-11047 once every 2 weeks; CGC-11047 once every four weeks

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Progen Pharmaceuticals: lead

Study Sites (8)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Dr. Quiroz-Mercado

Mexico City, District Federal, Mexico

Location

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

Location

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

Location

Closed Joint Stock Company "Inter YuNA"

Rostov-on-Don, Russia

Location

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

Location

Saint Petersburg State Healthcare Establishment "City Consultative Diagnostic Centre #1"

Saint Petersburg, Russia

Location

State Educational Establishment of Higher Professional Education "Military Medical Academy named by SM Kirov"

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

CGC 11047; (N(1),N(12))bis(ethyl)-6,7-dehydrospermine

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed: 100 patients were planned; 43 patients were recruited.

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Progen Pharmacauticals Ltd

+61 7 32739133

Study Officials

• Peter Campochiaro, MD

  Wilmer Eye Institute, Johns Hopkins Hospital School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 13, 2007
• Study Start: April 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 6, 2012
• Results First Posted: August 6, 2012

Record last verified: 2012-06

Locations

ME (1); US (1); RU (6)