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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
16.5 mg (3.3%) subconjunctival injection
Wilmer Eye Institute
Baltimore, Maryland, United States
Dr. Quiroz-Mercado
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
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
Safety of 2-weekly or 4-weekly Administration of CGC-11047
Time frame: 3 months
To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization
Time frame: 3 months
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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