Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy (NCT06164587) | Clinical Trial Compass
CompletedPhase 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 range
50 Years – 99 Years
Sex
ALL
See this in plain English?
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events
Timeframe: Within the study period (of 26 weeks)
2
Mean change in best-corrected visual acuity (BCVA)
Timeframe: At baseline visit, week 13 visit, and week 26 visit
3
Mean change in low-luminance best-corrected visual acuity (ll-BCVA)
Timeframe: At baseline visit, week 13 visit, and week 26 visit
4
Change in size of geographic atrophy (GA) on fundus autofluorescence (FAF)
Timeframe: At baseline visit, week 13 visit, and week 26 visit
5
change in size of geographic atrophy (GA) on optical coherence tomography (OCT)
Timeframe: At baseline visit, week 13 visit, and week 26 visit
6
change in size of geographic atrophy (GA) on fluorescein angiogram (FA)
Timeframe: At baseline visit, week 13 visit, and week 26 visit
7
Change in multifocal electroretinograms (mfERG) response