Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Inflammasome Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with geographic atrophy associated with age-related macular degeneration | Experimental | Kamuvudine-8 treatment (0.3 mg) at baseline visit and week 13 visit, in one eye of each subject, for a total of up to 30 subjects. When new study drug is received, the next 20 patients will be enrolled to receive K8 treatment (either 0.7 mg or 1.05 mg) at baseline and week 13, in one eye of each subject, for a total of up to 30 subjects. The total of 30 patients is across three dosing groups. Once subjects have received one dose/type of implant, there is no crossover to a different group. Patients will be followed for 26 weeks after baseline visit injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K8 | Drug | sustained released bio-erodible intravitreal implants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Frequency of participants experiencing ocular or systemic adverse events. | Within the study period (of 26 weeks) |
| Mean change in best-corrected visual acuity (BCVA) | 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) | At baseline visit, week 13 visit, and week 26 visit |
| Mean change in low-luminance best-corrected visual acuity (ll-BCVA) | best-corrected visual acuity in low-lighting settings | At baseline visit, week 13 visit, and week 26 visit |
| Change in size of geographic atrophy (GA) on fundus autofluorescence (FAF) | Change in total area of geographic atrophy lesions as analyzed with FAF imaging over the course of the trial | At baseline visit, week 13 visit, and week 26 visit |
| change in size of geographic atrophy (GA) on optical coherence tomography (OCT) | Change in total area of geographic atrophy lesions as analyzed with OCT imaging | At baseline visit, week 13 visit, and week 26 visit |
| change in size of geographic atrophy (GA) on fluorescein angiogram (FA) | Change in total area of geographic atrophy lesions as analyzed with FA imaging | At baseline visit, week 13 visit, and week 26 visit |
| Change in multifocal electroretinograms (mfERG) response |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best corrected visual acuity (BCVA) over multiple time points | Change in best corrected visual acuity (BCVA) at each study visit | Day 2 visit, Week 4 visit, Week 13 visit, Week 13 + 2 Days visit, and Week 17 visit |
Not provided
Inclusion Criteria:
General Exclusion Criteria:
Ocular Exclusion Criteria:
Prohibited Medications/Treatments:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michelle Abou-Jaoude, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States | ||
| University of Kentucky Advanced Eye Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017419 | Potassium, Dietary |
| ID | Term |
|---|---|
| D017680 | Potassium Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| At baseline visit, week 13 visit, and week 26 visit |
| Change in microperimetry response | 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). | At baseline visit, week 13 visit, and week 26 visit |
| Change in reading speed | Change in reading speed as measured by Radner reading chart procedure | At baseline visit, week 13 visit, and week 26 visit |
| Discontinued subjects | Number of subjects exiting study for any reason | This will be done at every scheduled visit and any unscheduled visit, as well as when reported by participants (for 26 weeks) |
| 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 |