Age Related Macular Degeneration
Conditions
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.
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.
Interventions
DRUGCGC-11047
16.5 mg (3.3%) subconjunctival injection
Sponsors
Progen Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Mexico, Russia, United States
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.
Participants by arm
| Arm | Count |
|---|---|
| CGC-11047 Once Every 2 Weeks 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks. | 21 |
| CGC-11047 Once Every Four Weeks 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks. | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | CGC-11047 Once Every Four Weeks | CGC-11047 Once Every 2 Weeks | Total |
|---|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 15 participants | 13 participants | 28 participants |
| Age Categorical Between 18 and 65 years | 3 participants | 7 participants | 10 participants |
| Age Continuous | 68.1 years STANDARD_DEVIATION 7 | 69.3 years STANDARD_DEVIATION 8.5 | 68.7 years STANDARD_DEVIATION 7.7 |
| Gender Female | 12 participants | 12 participants | 24 participants |
| Gender Male | 6 participants | 8 participants | 14 participants |
| Region of Enrollment Mexico | 1 participants | 5 participants | 6 participants |
| Region of Enrollment Russian Federation | 20 participants | 14 participants | 34 participants |
| Region of Enrollment United States | 1 participants | 2 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 21 | 2 / 22 |
| serious Total, serious adverse events | 2 / 21 | 0 / 22 |
Outcome results
Primary
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.
Time frame: Baseline and 3 months
Population: Analysis was performed on all patients who received at least one treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGC-11047 Once Every 2 Weeks | Change in Baseline to 3 Months in Best Corrected Visual Acuity | -0.01 logMAR | Standard Deviation 0.21 |
| CGC-11047 Once Every Four Weeks | Change in Baseline to 3 Months in Best Corrected Visual Acuity | 0.08 logMAR | Standard Deviation 0.25 |
Secondary
Safety of 2-weekly or 4-weekly Administration of CGC-11047
Time frame: 3 months
Secondary
To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization
Time frame: 3 months