Age-Related Macular Degeneration, Geographic Atrophy
Conditions
Keywords
ophthalmology, K8, kamuvudine
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 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.
Interventions
DRUGK8
sustained released bio-erodible intravitreal implants
Sponsors
Inflammasome Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Within the study period (of 26 weeks) | Frequency of participants experiencing ocular or systemic adverse events. |
| Mean change in best-corrected visual acuity (BCVA) | At baseline visit, week 13 visit, and week 26 visit | best-corrected visual acuity as defined by the number of letters read on the scale set by the ETDRS (Early Treatment of Diabetic Retinopathy Study). (More letters read equates to better visual acuity) |
| Mean change in low-luminance best-corrected visual acuity (ll-BCVA) | At baseline visit, week 13 visit, and week 26 visit | best-corrected visual acuity in low-lighting settings |
| Change in size of geographic atrophy (GA) on fundus autofluorescence (FAF) | At baseline visit, week 13 visit, and week 26 visit | Change in total area of geographic atrophy lesions as analyzed with FAF imaging over the course of the trial |
| change in size of geographic atrophy (GA) on optical coherence tomography (OCT) | At baseline visit, week 13 visit, and week 26 visit | Change in total area of geographic atrophy lesions as analyzed with OCT imaging |
| change in size of geographic atrophy (GA) on fluorescein angiogram (FA) | At baseline visit, week 13 visit, and week 26 visit | Change in total area of geographic atrophy lesions as analyzed with FA imaging |
| Change in multifocal electroretinograms (mfERG) response | At baseline visit, week 13 visit, and week 26 visit | Total response change measured by mfERG (performed upon site PI discretion and only if site has), which measures the electrical signal generated by a functionining eye processing information |
| Change in microperimetry response | At baseline visit, week 13 visit, and week 26 visit | change in response to visual field testing with microperimetry (undilated) over the course of the study (performed upon site PI discretion and only if site has). |
| Change in reading speed | At baseline visit, week 13 visit, and week 26 visit | Change in reading speed as measured by Radner reading chart procedure |
| Discontinued subjects | This will be done at every scheduled visit and any unscheduled visit, as well as when reported by participants (for 26 weeks) | Number of subjects exiting study for any reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in best corrected visual acuity (BCVA) over multiple time points | Day 2 visit, Week 4 visit, Week 13 visit, Week 13 + 2 Days visit, and Week 17 visit | Change in best corrected visual acuity (BCVA) at each study visit |
Countries
United States
Outcome results
None listed