AMEND: QA102 Phase II Study in Subjects With Dry AMD
Study Details
Study Description
Brief Summary
This is a phase 2, double-masked, randomized, placebo-controlled, dose-response study. The primary objective of the study is to evaluate the efficacy of QA102 oral capsules on the development of GA or CNV in high-risk eyes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Approximately 30 sites will randomize a total of approximately 240 subjects to 1 of 3 treatment arms in a 1:1:1 ratio (80 subjects per arm). Each subject will receive either QA102 or matching placebo BID for up to 24 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QA102 200mg 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 |
Drug: QA102/Placebo
Capsules
|
| Experimental: QA102 400mg group 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 |
Drug: QA102
Capsules
|
| Placebo Comparator: Placebo group Subjects randomized to this arm will receive two (2) placebo capsules BID = daily dose of 0 mg QA102 for up to 24 months |
Drug: Placebo
Capsules
|
Outcome Measures
Primary Outcome Measures
- proportion of subjects with disease progression to CNV or significant GA change as defined in the protocol [Month 24]
In the study eye at Month 24, proportion of subjects with disease progression as defined in the protocol.
Secondary Outcome Measures
- change from Baseline in BCVA [Month 1,2,3,6,9,12,15,18,21,24]
change from Baseline in best-corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS).
- The estimated mean rate of growth (slope) based on GA area [at ≥3 time points]
The estimated mean rate of growth (slope) based on GA area measured by FAF at ≥3 time points.
- Change from Baseline in soft drusen (drusen volume, drusen size) [Month 1,2,3,6,9,12,15,18,21,24]
Change from Baseline in soft drusen (drusen volume, drusen size) as measured by SD-OCT
- Change from Baseline in GA area [Month 1,2,3,6,9,12,15,18,21,24]
Change of Baseline GA area to on-treatment GA area assessments
- Area under the curve for BCVA letters read on the ETDRS chart over the 24-month treatment period [Month 1,2,3,6,9,12,15,18,21,24]
Change from baseline BCVA letters read on the ETDRS chart to on-treatment assessments
Other Outcome Measures
- Changes from baseline in gut microbiota [Month 24]
Eligibility Criteria
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.
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Subject must be age ≥50 years at the time of informed consent.
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Subject must be able to take oral medications and willing to record daily adherence to taking their assigned capsules.
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Subject must have adequate hematologic function, hepatic function, renal function and coagulation profile as defined in the protocol.
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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:
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Subject participated in another clinical study within 6 weeks prior to Screening.
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Subject is unwilling to stop intake of Age-Related Eye Disease Studies (AREDS) vitamins for the duration of the study.
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Subject has a clinically significant systemic disease that might interfere with the study, in the judgment of the Investigator.
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Subject had major surgery within 30 days prior to Screening.
Specific to Study Eye:
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Subject has large GA, subfoveal GA, or active or inactive CNV, as confirmed by the CRC.
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Subject has GA or CNV due to causes other than AMD that that developed between Visit 1 (Screening) and Visit 2 (Randomization).
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Subject has endophthalmitis.
Specific to Either Eye:
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Subject had intraocular surgery with lens replacement within 3 months of Screening.
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Subject has any ophthalmic condition that could require surgery during the study period.
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Subject has an ocular condition that might affect adequate imaging of the retina and/or or alter visual acuity.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Smilebiotek Zhuhai Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QA102-CS201