Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

NCT06164587 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 91507
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 9

Brief Summary

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. Number of participants has been expanded to 30. 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

Geographic Atrophy; Age-Related Macular Degeneration

Keywords

ophthalmology; K8; kamuvudine

Outcome Measures

Primary Outcomes (10)

• Adverse Events

  Frequency of participants experiencing ocular or systemic adverse events.

  Within the study period (of 26 weeks)

• Mean change in best-corrected visual acuity (BCVA)

  best-corrected visual acuity as defined by the number of letters read on the scale set by the ETDRS (Early Treatment of Diabetic Retinopathy Study). (More letters read equates to better visual acuity)

  At baseline visit, week 13 visit, and week 26 visit

• Mean change in low-luminance best-corrected visual acuity (ll-BCVA)

  best-corrected visual acuity in low-lighting settings

  At baseline visit, week 13 visit, and week 26 visit

• Change in size of geographic atrophy (GA) on fundus autofluorescence (FAF)

  Change in total area of geographic atrophy lesions as analyzed with FAF imaging over the course of the trial

  At baseline visit, week 13 visit, and week 26 visit

• change in size of geographic atrophy (GA) on optical coherence tomography (OCT)

  Change in total area of geographic atrophy lesions as analyzed with OCT imaging

  At baseline visit, week 13 visit, and week 26 visit

• change in size of geographic atrophy (GA) on fluorescein angiogram (FA)

  Change in total area of geographic atrophy lesions as analyzed with FA imaging

  At baseline visit, week 13 visit, and week 26 visit

• Change in multifocal electroretinograms (mfERG) response

  Total response change measured by mfERG (performed upon site PI discretion and only if site has), which measures the electrical signal generated by a functionining eye processing information

  At baseline visit, week 13 visit, and week 26 visit

• Change in microperimetry response

  change in response to visual field testing with microperimetry (undilated) over the course of the study (performed upon site PI discretion and only if site has).

  At baseline visit, week 13 visit, and week 26 visit

• Change in reading speed

  Change in reading speed as measured by Radner reading chart procedure

  At baseline visit, week 13 visit, and week 26 visit

• Discontinued subjects

  Number of subjects exiting study for any reason

  This will be done at every scheduled visit and any unscheduled visit, as well as when reported by participants (for 26 weeks)

Secondary Outcomes (1)

• Change in best corrected visual acuity (BCVA) over multiple time points

  Day 2 visit, Week 4 visit, Week 13 visit, Week 13 + 2 Days visit, and Week 17 visit

Study Arms (1)

Patients with geographic atrophy associated with age-related macular degeneration

EXPERIMENTAL

Kamuvudine-8 treatment (0.3 mg) at baseline visit and week 13 visit, in one eye of each subject, for a total of up to 30 subjects. When new study drug is received, the next 20 patients will be enrolled to receive K8 treatment (either 0.7 mg or 1.05 mg) at baseline and week 13, in one eye of each subject, for a total of up to 30 subjects. The total of 30 patients is across three dosing groups. Once subjects have received one dose/type of implant, there is no crossover to a different group. Patients will be followed for 26 weeks after baseline visit injection.

Drug: K8

Interventions

K8 DRUG

sustained released bio-erodible intravitreal implants

Also known as: SOM-401

Patients with geographic atrophy associated with age-related macular degeneration

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Both eyes must have GA and the total GA area in each eye 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.
• 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.

You may not qualify if:

• 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 or medication use that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study
• 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 AMD that may confound results
• Any history or current evidence of exudative ("wet") AMD including any evidence of retinal pigment epithelium rips or evidence of retinal, choroidal, or peripapillary neovascularization in either eye
• Known hypersensitivity to study drug or any of the excipients in implant
• Macular atrophy secondary to a condition other than AMD
• History of laser therapy in the macular region
• History of prior posterior vitrectomy
• History of prior intraocular gene therapy for any indication
• History of extended hydroxychloroquine or pentosan polysulfate exposure (\> 3 months)
• Current use of medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine \[Plaquenil®\], tamoxifen, phenothiazines, ethambutol, digoxin, pentosan polysulfate, and aminoglycosides).

Sponsors & Collaborators

• Michelle Abou-Jaoude: lead
• Inflammasome Therapeutics: collaborator

Study Sites (9)

Loma Linda University

Loma Linda, California, 92354, United States

Location

University of Kentucky Advanced Eye Care

Lexington, Kentucky, 40508, United States

Location

The Maine Eye Center

Portland, Maine, 04101, United States

Location

Oregon Eye Consultants, Cascade Medical Research

Eugene, Oregon, 97401, United States

Location

Hilton Head Retina Institute

Hilton Head, South Carolina, 29926-2277, United States

Location

Ophthalmology LTD

Sioux Falls, South Dakota, 57108, United States

Location

Southeastern Retina Associates

Hixson, Tennessee, 37343, United States

Location

Southeastern Retina Associates

Bristol, Virginia, 24201, United States

Location

Vistar Eye Center

Roanoke, Virginia, 24019, United States

Location

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Interventions

Potassium, Dietary

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Potassium Compounds; Inorganic Chemicals

Study Officials

• Michelle Abou-Jaoude, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: April 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)