ACTIVE_NOT_RECRUITING

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

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Conditions

Geographic AtrophyAge-Related Macular DegenerationophthalmologyK8kamuvudine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-18
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06164587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 50 or older, diagnosed with geographic atrophy (GA) due to age-related macular degeneration (AMD).
  2. * Best corrected visual acuity (BCVA) 24 or greater Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (approximately Snellen 20/320 or greater), in study eye.
  3. * The entire geographic atrophy (GA) lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy except in such cases where there is a "neck" or some narrow area connecting the GA with the peripapillary atrophy, as determined by Fundus Autofluorescence (FAF) imaging at screening:
  4. * Both eyes must have GA and the total GA area in each eye must be ≥ 2.5 and ≤ 20.0 mm2 (1 and 8 disk areas \[DA\] respectively)
  5. * If geographic atrophy (GA) is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above.
  6. * If geographic atrophy (GA) is unifocal, then the lesion must be extrafoveal.
  7. * Presence of any pattern of hyperautofluorescence in the junctional zone of geographic atrophy (GA). Absence of hyperautofluorescence (i.e., pattern = none) is exclusionary.
  8. * Fundus Autofluorescence (FAF), spectral-domain optical coherence tomography (SD-OCT), or Fluorescein Angiography (FA) imaging of entire geographic atrophy (GA)lesion at least 6 months prior to entry.
  1. * Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception
  2. * History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator
  3. * Participation in any investigational drug or device study within 30 days prior to baseline
  4. * History or current evidence of a medical condition or medication use that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study
  5. * Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.

Contacts and Locations

Principal Investigator

Michelle Abou-Jaoude, MD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

Loma Linda University
Loma Linda, California, 92354
United States
University of Kentucky Advanced Eye Care
Lexington, Kentucky, 40508
United States
The Maine Eye Center
Portland, Maine, 04101
United States
Oregon Eye Consultants, Cascade Medical Research
Eugene, Oregon, 97401
United States
Hilton Head Retina Institute
Hilton Head, South Carolina, 29926-2277
United States
Ophthalmology LTD
Sioux Falls, South Dakota, 57108
United States
Southeastern Retina Associates
Hixson, Tennessee, 37343
United States
Southeastern Retina Associates
Bristol, Virginia, 24201
United States
Vistar Eye Center
Roanoke, Virginia, 24019
United States

Collaborators and Investigators

Sponsor: Michelle Abou-Jaoude

  • Michelle Abou-Jaoude, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-04-18
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • ophthalmology
  • K8
  • kamuvudine

Additional Relevant MeSH Terms

  • Geographic Atrophy
  • Age-Related Macular Degeneration