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Purpose

This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study treatment will be administered by intravitreal injections. Participants will have 7 scheduled visits - Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response.

Conditions

Eligibility

Eligible Ages
Between 50 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patients with geographic atrophy associated with age-related macular degeneration 		Kamuvudine-8 treatment (0.3 mg) at baseline visit and week 13 visit, in one eye of each subject, for a total of 5 subjects. Patients will be followed for 26 weeks after baseline visit injection.
  • Drug: K8
    sustained released intravitreal implants
    Other names:
    • SOM-401

Recruiting Locations

University of Kentucky Advanced Eye Care
Lexington, Kentucky 40508

More Details

NCT ID
NCT06164587
Status
Recruiting
Sponsor
University of Kentucky

Study Contact

Sara Kuhl
859-562-3570
sara.kuhl@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.