QA102 Phase II Study in Subjects With Dry AMD (AMEND)
Dry Age-related Macular Degeneration
About this trial
This is an interventional treatment trial for Dry Age-related Macular Degeneration
Eligibility Criteria
Key Inclusion Criteria:
- Subject must be able to understand and willing to sign a written informed consent form (ICF) prior to the initiation of any study-specific procedures.
- Subject must be age ≥50 years at the time of informed consent.
- Subject must be able to take oral medications and willing to record daily adherence to taking their assigned capsules.
- Subject must have adequate hematologic function, hepatic function, renal function and coagulation profile as defined in the protocol.
- Subject must be willing and able to comply with study procedures and examinations.
Specific to the Study Eye:
Subject must have one of the following:
- extensive intermediate-size drusen, or at least 1 large drusen, or
- at least one GA secondary to AMD, with very limited aggregate size of total GA(s), as defined in the protocol.
- Subject must be able to correctly identify ≥35 ETDRS letters (approximately 20/200 Snellen equivalent).
Specific to Fellow Eye:
- Subject must have had a diagnosis of advanced AMD (GA or CNV) within the 12 months prior to screening.
Specific to Both Eyes:
- Subject must have visualizable retina, clear ocular media, and adequate pupillary dilation to ensure high-quality fundus imaging.
Key Exclusion Criteria:
- Subject participated in another clinical study within 6 weeks prior to Screening.
- Subject is unwilling to stop intake of Age-Related Eye Disease Studies (AREDS) vitamins for the duration of the study.
- Subject has a clinically significant systemic disease that might interfere with the study, in the judgment of the Investigator.
- Subject had major surgery within 30 days prior to Screening.
Specific to Study Eye:
- Subject has large GA, subfoveal GA, or active or inactive CNV, as confirmed by the CRC.
- Subject has GA or CNV due to causes other than AMD that that developed between Visit 1 (Screening) and Visit 2 (Randomization).
- Subject has endophthalmitis.
Specific to Either Eye:
- Subject had intraocular surgery with lens replacement within 3 months of Screening.
- Subject has any ophthalmic condition that could require surgery during the study period.
- Subject has an ocular condition that might affect adequate imaging of the retina and/or or alter visual acuity.
Sites / Locations
- Texas Retina Associates - Plano
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
QA102 200mg group
QA102 400mg group
Placebo group
Subjects randomized to this arm will receive one (1) 200 mg capsule of QA102 and 1 placebo capsule BID = daily dose of 400 mg QA102 for up to 24 months
Subjects randomized to this arm will receive two (2) 200 mg capsules of QA102 BID = daily dose of 800 mg QA102 for up to 24 months
Subjects randomized to this arm will receive two (2) placebo capsules BID = daily dose of 0 mg QA102 for up to 24 months