Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

Launched by UNIVERSITY OF KENTUCKY · Dec 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Kamuvudine-8 (K8) for patients with geographic atrophy (GA), a type of vision loss caused by age-related macular degeneration (AMD). The main goal is to evaluate how safe the treatment is and whether it can help improve vision or slow down the progression of GA. The trial will take place over 26 weeks at a single center, with up to 5 participants receiving injections of the study medication directly into the eye.

To participate, individuals need to be at least 50 years old and have been diagnosed with geographic atrophy. They should have a certain level of vision and specific characteristics of their GA lesions that can be seen on imaging tests. Participants will have a total of 7 visits, including initial screenings, treatment sessions, and follow-up appointments to monitor their vision and the condition of their eyes. It's important to note that certain medical conditions and recent treatments might exclude someone from joining the study. This trial is currently recruiting, so if you or someone you know is interested, you may want to check if they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 50 or older, diagnosed with geographic atrophy (GA) due to age-related macular degeneration (AMD).
• • Best corrected visual acuity (BCVA) 24 or greater Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (approximately Snellen 20/320 or greater), in study eye.
• * The entire geographic atrophy (GA) lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy except in such cases where there is a "neck" or some narrow area connecting the GA with the peripapillary atrophy, as determined by Fundus Autofluorescence (FAF) imaging at screening:
• • Total geographic atrophy (GA) area must be ≥ 2.5 and ≤ 20.0 mm2 (1 and 8 disk areas \[DA\] respectively)
• • If geographic atrophy (GA) is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above.
• • If geographic atrophy (GA) is unifocal, then the lesion must be extrafoveal.
• • Presence of any pattern of hyperautofluorescence in the junctional zone of geographic atrophy (GA). Absence of hyperautofluorescence (i.e., pattern = none) is exclusionary.
• • Fundus Autofluorescence (FAF), spectral-domain optical coherence tomography (SD-OCT), or Fluorescein Angiography (FA) imaging of entire geographic atrophy (GA)lesion at least 6 months prior to entry.
• Exclusion Criteria:
• • Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
• • History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
• • Participation in any investigational drug or device study within 30 days prior to baseline
• • History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
• • Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
• • Active ocular or periocular infections, malignancy
• • History of major ophthalmic surgery in the past 3 months, and any ophthalmic surgery in study eye in the last 30 days
• • History of significant ocular disease other than age-related macular degeneration (AMD) that may confound results
• • Known hypersensitivity to study drug or any of the excipients in implant.
• • Macular atrophy secondary to a condition other than age-related macular degeneration (AMD)
• • History of laser therapy in the macular region.
• • Aphakia or surgically compromised/absent posterior capsule including presence of scleral fixated lenses. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
• • History of prior posterior vitrectomy.
• • History of prior intraocular gene therapy for any indication.
• • Uncontrolled glaucoma (defined as intraocular pressure \>21mm Hg despite treatment with ocular hypotensive medications at baseline).
• • Prior participation in another interventional clinical study or treatment for GA in either eye including topical, IVT, subretinal, suprachoroidal, periocular or oral medication or placebo within the last 6 weeks or 5 half-lives of the active ingredient (whichever is longer).