The goal of this study is to evaluate how safe and tolerable KRIYA-825 (VV-14295) is and to determine how effective it is in reducing the growth of geographic atrophy (GA) lesions in the treated eye in patients with GA secondary to age-related macular degeneration (AMD).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
VV-14295 will be administered as a single suprachoroidal injection.
Kriya Clinical Study Site
Ottawa, Ontario, Canada
RECRUITINGKriya Clinical Study Site
Christchurch, New Zealand
RECRUITINGIncidence and severity of ocular and non-ocular adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and abnormal ophthalmic findings
Evaluate Part 1 safety of VV-14295 in foveal and non-foveal patients
Time frame: 12 months
Incidence and severity of ocular and non-ocular adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal ECGs, and abnormal ophthalmic findings
Evaluate Part 2 safety of VV-14295 in non-foveal GA patients
Time frame: 12 months
Rate of GA progression as assessed by optical coherence tomography (OCT)
Part 2 efficacy of VV-14295
Time frame: 12 months
Rate of GA progression as assessed by fundus autofluorescence (FAF)
Parts 1 and 2 efficacy of VV-14295
Time frame: 3, 6, and 12 months
Rate of GA progression as assessed by OCT
Parts 1 and 2 efficacy of VV-14295
Time frame: 3, 6, and 12 months
Visual function preservation as assessed by best-corrected visual acuity (BCVA)
Parts 1 and 2 efficacy of VV-14295
Time frame: 3, 6, and 12 months
Visual function preservation as assessed by low luminance visual acuity (LLVA)
Parts 1 and 2 efficacy of VV-14295
Time frame: 3, 6, and 12 months
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Visual function preservation as assessed by microperimetry
Parts 1 and 2 efficacy of VV-14295
Time frame: 3, 6, and 12 months
VV-14295 transgene product expression
Concentrations of AAV vector-mediated transgene product in serum
Time frame: 12 months
Immune response to VV-14295
Humoral and cellular responses to AAV2 capsid and transgene product; anti-AAV2 neutralization capacity in serum
Time frame: 12 months
Vector shedding profile of VV-14295
Vector shedding in serum, tears, mucus, and urine
Time frame: 12 months
Safety of Everads Injector
Frequency of device-related adverse events and serious adverse events
Time frame: 1 day post-dose