Active — Not RecruitingPhase 1/2

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

United States30 participantsStarted 2024-04-18

Plain-language 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.

Who can participate

Age range50 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Females who are pregnant, nursing, …

What they're measuring

Adverse Events

Timeframe: Within the study period (of 26 weeks)

Mean change in best-corrected visual acuity (BCVA)

Timeframe: At baseline visit, week 13 visit, and week 26 visit

Mean change in low-luminance best-corrected visual acuity (ll-BCVA)

Timeframe: At baseline visit, week 13 visit, and week 26 visit

Change in size of geographic atrophy (GA) on fundus autofluorescence (FAF)

Timeframe: At baseline visit, week 13 visit, and week 26 visit

change in size of geographic atrophy (GA) on optical coherence tomography (OCT)

Timeframe: At baseline visit, week 13 visit, and week 26 visit

change in size of geographic atrophy (GA) on fluorescein angiogram (FA)

Timeframe: At baseline visit, week 13 visit, and week 26 visit

Change in multifocal electroretinograms (mfERG) response

Timeframe: At baseline visit, week 13 visit, and week 26 visit

Trial details

NCT IDNCT06164587

SponsorMichelle Abou-Jaoude

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

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