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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

Primary Purpose

Age Related Macular Degeneration

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

CGC-11047

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Wilmer Eye Institute
Dr. Quiroz-Mercado
Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development
Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development
Closed Joint Stock Company "Inter YuNA"
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 State Healthcare Establishment "City Consultative Diagnostic Centre #1"
State Educational Establishment of Higher Professional Education "Military Medical Academy named by SM Kirov"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CGC-11047 once every 2 weeks

CGC-11047 once every four weeks

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety of 2-weekly or 4-weekly Administration of CGC-11047

To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization

Full Information

NCT ID

NCT00446654

First Posted

March 9, 2007

Last Updated

June 28, 2012

Sponsor

Progen Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00446654

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Progen Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age Related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CGC-11047 once every 2 weeks

Arm Type

Experimental

Arm Description

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

Arm Title

CGC-11047 once every four weeks

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CGC-11047

Other Intervention Name(s)

PG11047

Intervention Description

16.5 mg (3.3%) subconjunctival injection

Primary Outcome Measure Information:

Title

Change in Baseline to 3 Months in Best Corrected Visual Acuity

Description

Time Frame

Baseline and 3 months

Secondary Outcome Measure Information:

Title

Safety of 2-weekly or 4-weekly Administration of CGC-11047

Time Frame

3 months

Title

To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Campochiaro, MD

Organizational Affiliation

Wilmer Eye Institute, Johns Hopkins Hospital School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wilmer Eye Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Dr. Quiroz-Mercado

City

Mexico City

State/Province

District Federal

Country

Mexico

Facility Name

Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development

City

Cheboksary

Country

Russian Federation

Facility Name

Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development

City

Moscow

Country

Russian Federation

Facility Name

Closed Joint Stock Company "Inter YuNA"

City

Rostov-on-Don

Country

Russian Federation

Facility Name

Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development

City

St Petersburg

Country

Russian Federation

Facility Name

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

City

St Petersburg

Country

Russian Federation

Facility Name

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

City

St Petersburg

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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