Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Safety Study of 16.5mg (3.3%) CGC-11047 Injected Once Every 2 Weeks vs. Once Every 4 Weeks in Patients With CNV Due to Age Related Macular Degeneration
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cellgate
None
Information provided by: Cellgate
ClinicalTrials.gov Identifier: NCT00446654
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: CGC-11047 3.3% (16.5mg)
Phase I

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase Ib Randomized Open Label Study Between Once-Every-Two-Weeks and Once-Every-Four-Weeks Treatment of CGC-11047 in Patients With CNV Due to Age Related Macular Degeneration

Further study details as provided by Cellgate:

Primary Outcome Measures:
  • To obtain safety information for the use of CGC-11047 (16.5mg) as a subconjunctival injection for the treatment of AMD at once-every-two-weeks or once-every-four-weeks treatment intervals.

Secondary Outcome Measures:
  • To evaluate possible suppression and/or regression of choroidal neovascularization
  • In addition, to explore trends in BCVA in patients.

Estimated Enrollment: 100
Study Start Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446654

Locations
United States, California
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Florida
Southern Vitreoretinal Associates
Tallahassee, Florida, United States, 32308
Retina Group of Florida
Ft. Lauderdale, Florida, United States, 33334
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Mexico, District Federal
Dr. Quiroz-Mercado
Mexico City, District Federal, Mexico
Russian Federation
Various Cities, Russian Federation
Sponsors and Collaborators
Cellgate
None
Investigators
Principal Investigator: Peter Campochiaro, MD Wilmer Eye Institute, Johns Hopkins Hospital School of Medicine
  More Information

Study ID Numbers: 47-MD-002
Study First Received: March 9, 2007
Last Updated: August 29, 2007
ClinicalTrials.gov Identifier: NCT00446654  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009