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Anti-metabolites

Patients with geographic atrophy associated with age-related macular degeneration 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

K8 for GA Trial 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.Check my eligibility

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.See study design

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.

K8 for GA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Change in microperimetry response

Change in multifocal electroretinograms (mfERG) response

+7 more

Secondary outcome measures

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

K8 for GA 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of KentuckyLead Sponsor

187 Previous Clinical Trials

226,959 Total Patients Enrolled

Inflammasome TherapeuticsUNKNOWN

1 Previous Clinical Trials

5 Total Patients Enrolled

Michelle Abou-Jaoude, MDPrincipal InvestigatorUniversity of Kentucky

1 Previous Clinical Trials

5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA endorsed the treatment for individuals suffering from geographic atrophy linked to age-related macular degeneration?

"In this Phase 1 trial for patients with geographic atrophy linked to age-related macular degeneration, the safety ranking by our team stands at a level of 1 due to minimal existing evidence supporting both safety and effectiveness."

Answered by AI

Do I meet the criteria to participate in this medical trial?

"Additionally, participants are required to have undergone Fundus Autofluorescence (FAF), spectral-domain optical coherence tomography"

Answered by AI

Are individuals above the age of 40 eligible to participate in this medical study?

"The recruitment for this study targets individuals older than 50 years and below 99 years of age."

Answered by AI

What is the upper limit on the number of participants enrolled in this research endeavor?

"Indeed, data from clinicaltrials.gov confirms that this investigation is currently seeking participants. Initially made public on March 5th, 2024, and most recently modified on the same day, the study aims to recruit 5 patients from a single research site."

Answered by AI

Is this medical study currently open to new participants?

"As detailed on clinicaltrials.gov, this trial is actively soliciting volunteers. The initial posting date for the study was March 5th, 2024, and it was last revised on the same day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

Michelle Abou-Jaoude 2024. "Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06164587.