Kamuvudine-8 for Age-Related Macular Degeneration (K8 for GA Trial)

Phase 1

Recruiting

Led By Michelle Abou-Jaoude, MD

Research Sponsored by University of Kentucky

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2 visit, week 4 visit, week 13 visit, week 13 + 2 days visit, and week 17 visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a drug called K8 for treating geographic atrophy (GA) in patients with age-related macular degeneration (AMD). Up to 5 patients will

Who is the study for?

This trial is for individuals aged 50 or older with geographic atrophy (GA) due to age-related macular degeneration (AMD). Participants must have a certain size of GA lesion, visual acuity of approximately Snellen 20/320 or better, and specific patterns in diagnostic imaging. Those without the required hyperautofluorescence pattern are excluded.

What is being tested?

The study tests the safety and effectiveness of K8, administered through intravitreal injections over a period of 26 weeks. Patients will be monitored through visits and various eye exams to assess changes in vision, GA lesion area, retinal response, reading speed, and microperimetry.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from injections, inflammation inside the eye, possible changes in vision including blurriness or floaters following treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2 visit, week 4 visit, week 13 visit, week 13 + 2 days visit, and week 17 visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2 visit, week 4 visit, week 13 visit, week 13 + 2 days visit, and week 17 visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 visit, week 4 visit, week 13 visit, week 13 + 2 days visit, and week 17 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Change in microperimetry response

Change in multifocal electroretinograms (mfERG) response

+7 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with geographic atrophy associated with age-related macular degenerationExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2024

Completed Phase 1

~10

Do I qualify?Apply below to find out