Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446654
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2007-03-09
Brief Title:
Safety of 165 mg 33 CGC-11047 Once Every 2 Weeks vs Once Every 4 Weeks in Patients With CNV Due to AMD
Sponsor:
Progen Pharmaceuticals
Organization:
Progen Pharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hisher 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-Hodgkins 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
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-Hodgkins 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None