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NCT06164587 · ClinicalTrials.gov registry record · Phase 1

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

A Phase 1 study of Age-related Macular Degeneration and Geographic Atrophy, sponsored by Michelle Abou-Jaoude.

Active
Registry status
Phase 1
Development phase
30
Enrollment target
9
Study locations

NCT06164587 is a Phase 1 study of Age-related Macular Degeneration and Geographic Atrophy that is active but no longer recruiting, run by Michelle Abou-Jaoude. The registered enrollment target is 30 participants, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT06164587, a Phase 1 study of Age-related Macular Degeneration and Geographic Atrophy, is active but no longer recruiting, sponsored by Michelle Abou-Jaoude.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
9
Study locations

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

Age-related Macular Degeneration Geographic Atrophy

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

FieldValue
Enrollment Target 30 participants
Start Date 2024-04-18
Est. Completion 2026-06
Phase Phase 1

Sponsor

Michelle Abou-Jaoude

3 total trials

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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, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (98% lower). The listed sponsor is Michelle Abou-Jaoude, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT06164587 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Virginia, California, Kentucky.

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.

What interventions are being tested in trial NCT06164587?

The interventions under investigation include: K8 (DRUG).

Who is sponsoring clinical trial NCT06164587?

This trial is sponsored by Michelle Abou-Jaoude, which has 3 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.