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
Erie, Pennsylvania, United States
RECRUITINGKriya Clinical Study Site
Ottawa, Ontario, Canada
RECRUITINGKriya Clinical Study Site
Tel Aviv, Israel
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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Kriya Clinical Study Site
Christchurch, New Zealand
RECRUITINGVisual 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