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Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy
NCT06164587 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG K8
Study Locations (9)
Virginia
- Southeastern Retina Associates — Bristol
- Vistar Eye Center — Roanoke
California
- Loma Linda University — Loma Linda
Kentucky
- University of Kentucky Advanced Eye Care — Lexington
Maine
- The Maine Eye Center — Portland
Oregon
- Oregon Eye Consultants, Cascade Medical Research — Eugene
South Carolina
- Hilton Head Retina Institute — Hilton Head
South Dakota
- Ophthalmology LTD — Sioux Falls
Tennessee
- Southeastern Retina Associates — Hixson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06164587
The ClinicalTrials.gov registry entry for NCT06164587 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michelle Abou-Jaoude, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Age-Related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention — of which K8 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06164587 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Virginia, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06164587 about?
NCT06164587 is a clinical study titled "Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy". 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 admini...
What is the current status of trial NCT06164587?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-04-18. Estimated completion is 2026-06.
What conditions does trial NCT06164587 study?
This clinical trial studies the following conditions: Age-Related Macular Degeneration, Geographic Atrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06164587?
The interventions under investigation include: K8 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06164587?
This trial is sponsored by Michelle Abou-Jaoude, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06164587 being conducted?
This trial has 9 study locations across California, Kentucky, Maine, Oregon, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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