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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGC-11047 once every 2 weeks | Experimental | 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks. |
|
| CGC-11047 once every four weeks | Experimental | 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGC-11047 | Drug | 16.5 mg (3.3%) subconjunctival injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Campochiaro, MD | Wilmer Eye Institute, Johns Hopkins Hospital School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States | ||
| Dr. Quiroz-Mercado |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CGC-11047 Once Every 2 Weeks | 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks. |
| FG001 | CGC-11047 Once Every Four Weeks | 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CGC-11047 Once Every 2 Weeks | 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks. |
| BG001 | CGC-11047 Once Every Four Weeks | 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Demographic data is missing for 5 patients. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Safety of 2-weekly or 4-weekly Administration of CGC-11047 | Not Posted | 3 months | |||||||||||||
| Secondary | To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization | Not Posted | 3 months |
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGC-11047 Once Every 2 Weeks | 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Strangulate umbilical hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
Early termination leading to small numbers of subjects analyzed: 100 patients were planned; 43 patients were recruited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Progen Pharmacauticals Ltd | +61 7 32739133 |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C515675 | CGC 11047 |
| C415967 | (N(1),N(12))bis(ethyl)-6,7-dehydrospermine |
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| Mexico City |
| District Federal |
| Mexico |
| Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development | Cheboksary | Russia |
| Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development | Moscow | Russia |
| Closed Joint Stock Company "Inter YuNA" | Rostov-on-Don | Russia |
| 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 | Russia |
| Saint Petersburg State Healthcare Establishment "City Consultative Diagnostic Centre #1" | Saint Petersburg | Russia |
| State Educational Establishment of Higher Professional Education "Military Medical Academy named by SM Kirov" | Saint Petersburg | Russia |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Age Continuous | Demographic data is missing for 5 patients. | Mean | Standard Deviation | years |
|
| Gender | Demographic data is missing for 5 patients. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Analysis was performed on all patients who received at least one treatment. | Posted | Mean | Standard Deviation | logMAR | Baseline and 3 months |
|
|
|
| 2 |
| 21 |
| 7 |
| 21 |
| EG001 | CGC-11047 Once Every Four Weeks | 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks. | 0 | 22 | 2 | 22 |
| Loss of visual acuity | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Foreign body sensation in eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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