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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Texas Retina Associates - Plano
Plano, Texas, United States
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).
Time frame: Month 12
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).
Time frame: Month 12
Change from Baseline in LLVA
In the study eye at Month 12, change from baseline in low-luminance visual acuity (LLVA) as measured by ETDRS.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Month 1,2,3,6,9,12,15
Rescue injections
Proportion of subjects requiring rescue injections of anti-VEGF therapies for CNV.
Time frame: 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.
Time frame: 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.
Time frame: Month 1,2,3,6,9,12,15