Evaluating Kamuvudine-8 for treating geographic atrophy

A Non-Randomized, Open Label, Safety and Efficacy Study Evaluating Kamuvudine-8 (K8) for the Treatment of Patients With Geographic Atrophy

This study is testing if a new injection called Kamuvudine-8 can help people with geographic atrophy from age-related macular degeneration improve their vision and reduce eye damage.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 50 Years to 99 Years
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Locations: 5 sites (Lexington, Kentucky and 4 other locations)
• Trial ID: NCT06164587 on ClinicalTrials.gov

What this trial studies

This interventional study is designed to assess the safety and efficacy of Kamuvudine-8 (K8) in patients suffering from geographic atrophy (GA) due to age-related macular degeneration (AMD). The study will involve up to 30 participants who will receive intravitreal injections of K8 over a 26-week period, with multiple scheduled visits for monitoring visual acuity and changes in GA lesions. Participants will undergo various diagnostic imaging and assessments to evaluate the treatment's impact on their condition.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 or older diagnosed with geographic atrophy due to age-related macular degeneration.

Not a fit: Patients with severe visual impairment or those whose geographic atrophy lesions do not meet the specified criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve visual acuity and slow the progression of geographic atrophy in patients.

How similar studies have performed: While this approach is novel, similar studies targeting geographic atrophy have shown promise in the past.

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).

Where this trial is running

Lexington, Kentucky and 4 other locations

• University of Kentucky Advanced Eye Care — Lexington, Kentucky, United States (Recruiting)
• The Maine Eye Center — Portland, Maine, United States (Not_yet_recruiting)
• Oregon Eye Consultants, Cascade Medical Research — Eugene, Oregon, United States (Not_yet_recruiting)
• Ophthalmology LTD — Sioux Falls, South Dakota, United States (Recruiting)
• Vistar Eye Center — Roanoke, Virginia, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Michelle Abou-Jaoude, MD — University of Kentucky
• Study coordinator: Clayton Waldridge

Conditions Geographic Atrophy; Age-Related Macular Degeneration; ophthalmology; K8; kamuvudine