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).
Participant must be between 55 to 80 years of age (inclusive), at the time of signing the informed consent form.
Body mass index (BMI) of 19 to 34 kg/m2 (inclusive).
Must agree to use reliable contraception for at least 12 months after administration of VV-14295. A female participant is eligible to participate if she is not pregnant and not breastfeeding.
The GA lesion must meet certain criteria as assessed by a central reading center's assessment of imaging at Screening.
Any ocular disease or condition that is not GA secondary to AMD: Macular atrophy secondary to a condition other than AMD; Exudative AMD diagnosis or any history of or active macular neovascularization (in study eye or fellow eye) and/or retinal angiomatous proliferation associated with AMD or any other cause; Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function; Active ocular or periocular infection or active uncontrolled intraocular inflammation within 3 months of Screening; History of vitrectomy, retinal detachment, or corneal transplant in the study eye; Active/history of uveitis.
Any ocular condition that prevents adequate imaging.
Medical, cognitive or psychiatric conditions that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the risk to the participant by participating in the study or confound the outcome of the study.
Hospitalization within 1 year prior to Screening that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the risk to the participant by participating in the study or confound the outcome of the study.
Sequential
VV-14295
GeneticVV-14295 will be administered as a single suprachoroidal injection.
Incidence 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
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
Rate of GA progression as assessed by optical coherence tomography (OCT)
Part 2 efficacy of VV-14295
Rate of GA progression as assessed by fundus autofluorescence (FAF)
Parts 1 and 2 efficacy of VV-14295
Rate of GA progression as assessed by OCT
Parts 1 and 2 efficacy of VV-14295
Visual function preservation as assessed by best-corrected visual acuity (BCVA)
Parts 1 and 2 efficacy of VV-14295
Visual function preservation as assessed by low luminance visual acuity (LLVA)
Parts 1 and 2 efficacy of VV-14295
Click on the lead sponsor to view all of their trials.
