Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 soft drusen, visual acuity (VA), and geographic atrophy (GA) or choroidal neovascularization (CNV) or the progression of GA in subjects with intermediate to advanced dry AMD.
Approximately 30 sites will randomize a total of approximately 150 subjects to 1 of 3 treatment arms in a 1:1:1 ratio (50 subjects per arm). Each subject will receive either QA102 or matching placebo BID for up to 15 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QA102 200mg group | Experimental | 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 15 months |
|
| QA102 400mg group | Experimental | Subjects randomized to this arm will receive two (2) 200 mg capsules of QA102 BID = daily dose of 800 mg QA102 for up to 15 months |
|
| Placebo group | Placebo Comparator | Subjects randomized to this arm will receive two (2) placebo capsules BID = daily dose of 0 mg QA102 for up to 15 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QA102/Placebo | Drug | Capsules |
| |
| QA102 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in soft drusen volume (mm3) | In the study eye at Month 12, change from baseline in best-corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS). | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in BCVA | Change from Baseline in best-corrected visual acuity (BCVA) at month 12 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS). | Month 12 |
| Change from Baseline in LLVA |
Not provided
Key Inclusion Criteria:
Specific to the Study Eye:
Subject must have one of the following:
Subject must be able to correctly identify ≥35 ETDRS letters (approximately 20/200 Snellen equivalent).
Specific to Fellow Eye:
- Subject must have a diagnosis of advanced AMD (evidence of GA and/or CNV), to be confirmed by the CRC.
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:
Specific to Study Eye:
Specific to Fellow Eye:
Subject has monocular vision impairment, defined as having no light perception in the fellow eye with adequate vision in the study eye.
Specific to Either Eye:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Retina Associates - Plano | Plano | Texas | 75075 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Capsules |
|
| Placebo | Drug | Capsules |
|
In the study eye at Month 12, change from baseline in low-luminance visual acuity (LLVA) as measured by ETDRS.
| Month 12 |
| Change from baseline in soft drusen volume (mm3) | Change from baseline in drusen volume (mm3) as measured by SD-OCT at time points other than Month 12 (study eye) or at all time points (fellow eye). | Month 1,2,3,6,9,12,15 |
| Change from Baseline in BCVA | Change from baseline in BCVA as measured by ETDRS at time points other than Month 12 (study eye) or at all time points (fellow eye). | Month 1,2,3,6,9,12,15 |
| Change from Baseline in LLVA | Change from baseline in LLVA as measured by ETDRS at time points other than Month 12 (study eye) or at all time points (fellow eye). | Month 1,2,3,6,9,12,15 |
| Change from baseline in GA | Change from baseline in GA area as measured by fundus autofluorescence (FAF) and/or SD-OCT. | Month 1,2,3,6,9,12,15 |
| Change from baseline in GA | Change from baseline in GA area as measured by the square root transformation of area on FAF and/or SD-OCT. | Month 1,2,3,6,9,12,15 |
| Mean rate of GA growth | In the study eye, the estimated mean rate of growth (slope) based on GA area measured by FAF at ≥3 time points. | Month 1,2,3,6,9,12,15 |
| Area under the curve for BCVA letters | Area under the curve for BCVA letters read on the ETDRS chart over the 15-month treatment period. | Month 1,2,3,6,9,12,15 |
| Proportion of subjects with disease progression | In the study eye at Month 15, proportion of subjects with disease progression, defined as (a) development of CNV, as assessed by SD-OCT and/or FAF, or (b) GA change from baseline of ≥0.50 mm2, as assessed by FAF. Both assessments will be conducted by the central reading center (CRC). | Month 15 |
| Proportion of subjects with progression of GA | Proportion of subjects with progression of GA, defined as a change from baseline of ≥0.50 mm2, at time points other than Month 15 (study eye) or at all time points (fellow eye), as determined by the CRC using FAF and/or SD-OCT. | Month 1,2,3,6,9,12,15 |
| Rescue injections | Proportion of subjects requiring rescue injections of anti-VEGF therapies for CNV. | Month 1,2,3,6,9,12,15 |
| iRORA | Proportion of subjects developing new incomplete retinal pigment epithelium and outer retinal atrophy (iRORA), as determined by the CRC. | Month 1,2,3,6,9,12,15 |
| Fellow eye CNV | Proportion of subjects with CNV achieving optimal control of CNV, defined as the absence of subretinal fluid (SRF), at each time point. | Month 1,2,3,6,9,12,15 |