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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
sustained released bio-erodible intravitreal implants
Loma Linda University
Loma Linda, California, United States
University of Kentucky Advanced Eye Care
Lexington, Kentucky, United States
The Maine Eye Center
Portland, Maine, United States
Oregon Eye Consultants, Cascade Medical Research
Eugene, Oregon, United States
Hilton Head Retina Institute
Hilton Head, South Carolina, United States
Ophthalmology LTD
Sioux Falls, South Dakota, United States
Southeastern Retina Associates
Hixson, Tennessee, United States
Southeastern Retina Associates
Bristol, Virginia, United States
Vistar Eye Center
Roanoke, Virginia, United States
Adverse Events
Frequency of participants experiencing ocular or systemic adverse events.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline visit, week 13 visit, and week 26 visit
Change in multifocal electroretinograms (mfERG) response
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
Time frame: 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).
Time frame: 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
Time frame: At baseline visit, week 13 visit, and week 26 visit
Discontinued subjects
Number of subjects exiting study for any reason
Time frame: This will be done at every scheduled visit and any unscheduled visit, as well as when reported by participants (for 26 weeks)
Change in best corrected visual acuity (BCVA) over multiple time points
Change in best corrected visual acuity (BCVA) at each study visit
Time frame: Day 2 visit, Week 4 visit, Week 13 visit, Week 13 + 2 Days visit, and Week 17 visit
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