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

• Sponsor: Progen Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00446654
• Collaborator: (none)
• Enrollment: 43
• Locations: 8
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: CGC-11047	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: PG11047

Outcome Measures

Primary Outcome Measures

1. 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

1. Safety of 2-weekly or 4-weekly Administration of CGC-11047 [3 months]

2. To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Wilmer Eye Institute	Baltimore	Maryland	United States	21287
2	Dr. Quiroz-Mercado	Mexico City	District Federal	Mexico
3	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
4	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
5	Closed Joint Stock Company "Inter YuNA"	Rostov-on-Don		Russian Federation
6	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
7	Saint Petersburg State Healthcare Establishment "City Consultative Diagnostic Centre #1"	St Petersburg		Russian Federation
8	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Progen Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00446654
• Other Study ID Numbers: 47-MD-002
• First Posted: Mar 13, 2007
• Last Update Posted: Aug 6, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Macular Degeneration

Study Results

Participant Flow

Recruitment Details	The recruitment period spanned 05 February 2007 to 10 July 2007. Patients were randomised to one of the two treatment groups. Treatment group assignment for each patient was made centrally.

Arm/Group Title	CGC-11047 Once Every 2 Weeks	CGC-11047 Once Every Four Weeks
Arm/Group 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.
Period Title: Overall Study
STARTED	21	22
COMPLETED	19	22
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	CGC-11047 Once Every 2 Weeks	CGC-11047 Once Every Four Weeks	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	21	22	43
Age (participants) [Number]
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 33.3%	3 13.6%	10 23.3%
>=65 years	13 61.9%	15 68.2%	28 65.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.3 (8.5)	68.1 (7.0)	68.7 (7.7)
Gender (participants) [Number]
Female	12 57.1%	12 54.5%	24 55.8%
Male	8 38.1%	6 27.3%	14 32.6%
Region of Enrollment (participants) [Number]
United States	2 9.5%	1 4.5%	3 7%
Mexico	5 23.8%	1 4.5%	6 14%
Russian Federation	14 66.7%	20 90.9%	34 79.1%

Outcome Measures

1. Secondary Outcome

Title	Safety of 2-weekly or 4-weekly Administration of CGC-11047
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Secondary Outcome

Title	To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Change in Baseline to 3 Months in Best Corrected Visual Acuity
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Analysis was performed on all patients who received at least one treatment.

Arm/Group Title	CGC-11047 Once Every 2 Weeks	CGC-11047 Once Every Four Weeks
Arm/Group 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.
Measure Participants	21	21
Mean (Standard Deviation) [logMAR]	-0.01 (0.21)	0.08 (0.25)

Adverse Events

Time Frame	3 months
Arm/Group Title	CGC-11047 Once Every 2 Weeks		CGC-11047 Once Every Four Weeks
Arm/Group 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.
All Cause Mortality
	CGC-11047 Once Every 2 Weeks		CGC-11047 Once Every Four Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CGC-11047 Once Every 2 Weeks		CGC-11047 Once Every Four Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		0/22 (0%)
Eye disorders
Loss of visual acuity	1/21 (4.8%)	1	0/22 (0%)	0
Gastrointestinal disorders
Strangulate umbilical hernia	1/21 (4.8%)	1	0/22 (0%)	0
Other (Not Including Serious) Adverse Events
	CGC-11047 Once Every 2 Weeks		CGC-11047 Once Every Four Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/21 (33.3%)		2/22 (9.1%)
Eye disorders
Conjunctival haemorrhage	2/21 (9.5%)	4	1/22 (4.5%)	1
Eye pain	6/21 (28.6%)	12	1/22 (4.5%)	1
Foreign body sensation in eye	2/21 (9.5%)	5	0/22 (0%)	0
General disorders
Injection site pain	3/21 (14.3%)	3	0/22 (0%)	0
Pain	1/21 (4.8%)	3	1/22 (4.5%)	1

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.