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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00446654
First received: March 9, 2007
Last updated: June 28, 2012
Last verified: June 2012
  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
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Progen Pharmaceuticals:

Primary Outcome Measures:
  • Change in Baseline to 3 Months in Best Corrected Visual Acuity [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

    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:
  • Safety of 2-weekly or 4-weekly Administration of CGC-11047 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: April 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CGC-11047 once every 2 weeks
16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
Drug: CGC-11047
16.5 mg (3.3%) subconjunctival injection
Other Name: PG11047
Experimental: CGC-11047 once every four weeks
16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
Drug: CGC-11047
16.5 mg (3.3%) subconjunctival injection
Other Name: PG11047

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446654

Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Mexico
Dr. Quiroz-Mercado
Mexico City, District Federal, Mexico
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
Cheboksary, 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
Moscow, Russian Federation
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
Saint Petersburg State Healthcare Establishment "City Consultative Diagnostic Centre #1"
St Petersburg, Russian Federation
State Educational Establishment of Higher Professional Education "Military Medical Academy named by SM Kirov"
St Petersburg, Russian Federation
Sponsors and Collaborators
Progen Pharmaceuticals
Investigators
Principal Investigator: Peter Campochiaro, MD Wilmer Eye Institute, Johns Hopkins Hospital School of Medicine
  More Information

No publications provided

Responsible Party: Progen Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00446654     History of Changes
Other Study ID Numbers: 47-MD-002
Study First Received: March 9, 2007
Results First Received: May 29, 2012
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014