Phase
Condition
Geographic Atrophy
Macular Degeneration
Neoplasm Metastasis
Treatment
VV-14295
Clinical Study ID
Ages 55-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be between 55 to 80 years of age (inclusive), at the time ofsigning 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 administrationof VV-14295. A female participant is eligible to participate if she is not pregnantand not breastfeeding.
The GA lesion must meet certain criteria as assessed by a central reading center'sassessment of imaging at Screening.
Adequate clarity of ocular media, adequate pupillary dilation, and fixation topermit 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 (20/800or better) for Part 1a participants or 24 letters or better (approximately 20/320Snellen equivalent or better) for Part 1b and Part 2 participants. Fellow eye musthave equivalent or better visual acuity than the study eye.
Exclusion
Exclusion Criteria:
Any ocular disease or condition that is not GA secondary to AMD: Macular atrophysecondary to a condition other than AMD; Exudative AMD diagnosis or any history ofor active macular neovascularization (in study eye or fellow eye) and/or retinalangiomatous proliferation associated with AMD or any other cause; Presence of anactive ocular disease that in the opinion of the Investigator compromises orconfounds visual function; Active ocular or periocular infection or activeuncontrolled intraocular inflammation within 3 months of Screening; History ofvitrectomy, 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 theInvestigator, make consistent study assessment and follow-up over the 12-monthPost-Treatment Follow-up Period unlikely, or could increase the risk to theparticipant by participating in the study or confound the outcome of the study.
Hospitalization within 1 year prior to Screening that, in the opinion of theInvestigator, make consistent study assessment and follow-up over the 12-monthPost-Treatment Follow-up Period unlikely, or could increase the risk to theparticipant 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 theopinion of the Investigator and/or Medical Monitor is clinically significant andrenders the participant not suitable for study participation.
Participant has a direct contraindication to the steroid regimen (both oral andtopical) or has a condition that significantly increases the risk of complication.
Active/history of malignancy within the past 5 years from Screening or any previoustherapeutic radiation in the region of the study eye(s) at Screening. History ofnon-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervicalintraepithelial neoplasia (CIN), and localized prostate cancer after treatment arenot exclusionary.
Intraocular surgery (including lens replacement surgery) within 3 months prior toScreening.
History of laser therapy in the macular region.
History of intravitreal (IVT) therapy, such as IVT steroid injections, within 6months prior to Screening.
COVID-19 vaccine within 90 days of Screening or plan to receive COVID-19 vaccinewithin 6 months of treatment.
Active use of systemic immunomodulatory drugs or systemic corticosteroids in thelast 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.
Study Design
Connect with a study center
Kriya Clinical Study Site
Christchurch,
New ZealandActive - Recruiting
New Zealand Clinical Research (NZCR)
Christchurch,
New ZealandActive - Recruiting
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