a study to evaluate kriya-825 (vv-14295) in adults with geographic atrophy secondary to age-related macular degeneration

Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration

Summary: 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).


Eligibility criteria:
inclusion criteria: * 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. * adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the investigator. * for study eye, normal luminance bcva of 55 letters or worse using the etdrs charts (20/80 or worse) for part 1a participants or 24 letters or better (approximately 20/320 snellen equivalent) for part 1b and part 2 participants. * fellow eye normal luminance bcva of 5 letters or better using etdrs charts (20/800 or better) for part 1a participants or 24 letters or better (approximately 20/320 snellen equivalent or better) for part 1b and part 2 participants. fellow eye must have equivalent or better visual acuity than the study eye. exclusion criteria: * 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. * any screening test (e.g., ecg) or laboratory value (e.g., hematology) that in the opinion of the investigator and/or medical monitor is clinically significant and renders the participant not suitable for study participation. * participant has a direct contraindication to the steroid regimen (both oral and topical) or has a condition that significantly increases the risk of complication. * active/history of malignancy within the past 5 years from screening or any previous therapeutic radiation in the region of the study eye(s) at screening. history of non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia (cin), and localized prostate cancer after treatment are not exclusionary. * intraocular surgery (including lens replacement surgery) within 3 months prior to screening. * history of laser therapy in the macular region. * history of intravitreal (ivt) therapy, such as ivt steroid injections, within 6 months prior to screening. * covid-19 vaccine within 90 days of screening or plan to receive covid-19 vaccine within 6 months of treatment. * active use of systemic immunomodulatory drugs or systemic corticosteroids in the last 60 days. topical steroids are not exclusionary. * prior participation in another interventional clinical study for ga within the past 12 months from the last dosing at screening.