Status:
ACTIVE_NOT_RECRUITING
Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy
Lead Sponsor:
Michelle Abou-Jaoude
Collaborating Sponsors:
Inflammasome Therapeutics
Conditions:
Geographic Atrophy
Age-Related Macular Degeneration
Eligibility:
All Genders
50-99 years
Phase:
PHASE1
PHASE2
Brief 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 macula...
Eligibility Criteria
Inclusion
- Aged 50 or older, diagnosed with geographic atrophy (GA) due to age-related macular degeneration (AMD).
- 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.
- 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:
- 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)
- 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.
- If geographic atrophy (GA) is unifocal, then the lesion must be extrafoveal.
- Presence of any pattern of hyperautofluorescence in the junctional zone of geographic atrophy (GA). Absence of hyperautofluorescence (i.e., pattern = none) is exclusionary.
- 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.
- General
Exclusion
- Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception
- History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator
- Participation in any investigational drug or device study within 30 days prior to baseline
- 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
- 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.
- Ocular
Key Trial Info
Start Date :
April 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06164587
Start Date
April 18 2024
End Date
June 1 2026
Last Update
December 22 2025
Active Locations (9)
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1
Loma Linda University
Loma Linda, California, United States, 92354
2
University of Kentucky Advanced Eye Care
Lexington, Kentucky, United States, 40508
3
The Maine Eye Center
Portland, Maine, United States, 04101
4
Oregon Eye Consultants, Cascade Medical Research
Eugene, Oregon, United States, 97401