NCT06164587

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Michelle Abou-Jaoude · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	K8	sustained released bio-erodible intravitreal implants

Timeline

• Start date: 2024-04-18
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-12-11
• Last updated: 2025-12-22

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study