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ACTIVE NOT RECRUITING
NCT06164587
PHASE1/PHASE2

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

Sponsor: Michelle Abou-Jaoude

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-04-18

Completion Date

2026-06

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DRUG

K8

sustained released bio-erodible intravitreal implants

Locations (9)

Loma Linda University

Loma Linda, California, United States

University of Kentucky Advanced Eye Care

Lexington, Kentucky, United States

The Maine Eye Center

Portland, Maine, United States

Oregon Eye Consultants, Cascade Medical Research

Eugene, Oregon, United States

Hilton Head Retina Institute

Hilton Head, South Carolina, United States

Ophthalmology LTD

Sioux Falls, South Dakota, United States

Southeastern Retina Associates

Hixson, Tennessee, United States

Southeastern Retina Associates

Bristol, Virginia, United States

Vistar Eye Center

Roanoke, Virginia, United States