Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy
NCT ID: NCT06164587
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2024-04-18
2026-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with geographic atrophy associated with age-related macular degeneration
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.
K8
sustained released bio-erodible intravitreal implants
Interventions
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K8
sustained released bio-erodible intravitreal implants
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Active ocular or periocular infections, malignancy
* History of major ophthalmic surgery in the past 3 months, and any ophthalmic surgery in study eye in the last 30 days
* History of significant ocular disease other than AMD that may confound results
* Any history or current evidence of exudative ("wet") AMD including any evidence of retinal pigment epithelium rips or evidence of retinal, choroidal, or peripapillary neovascularization in either eye
* Known hypersensitivity to study drug or any of the excipients in implant
* Macular atrophy secondary to a condition other than AMD
* History of laser therapy in the macular region
* Aphakia or surgically compromised/absent posterior capsule including presence of scleral fixated lenses. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary
* History of prior posterior vitrectomy
* History of prior intraocular gene therapy for any indication
* History of extended hydroxychloroquine or pentosan polysulfate exposure (\> 3 months)
* Current use of medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine \[Plaquenil®\], tamoxifen, phenothiazines, ethambutol, digoxin, pentosan polysulfate, and aminoglycosides).
* Uncontrolled glaucoma (defined as intraocular pressure \>21mm Hg despite treatment with ocular hypotensive medications at baseline)
* Prior participation in another interventional clinical study or treatment for GA in the study eye including topical, IVT, subretinal, suprachoroidal, periocular or oral medication or placebo within 5 half-lives of the active ingredient
Prohibited Medications/Treatments:
* Systemic anti-VEGF medications
* Intravitreal injections of Syfovre (pegcetacoplan), Izervay (avacincaptad pegol) or other complement inhibitors in either eye
* Gene therapy injections in either eye
50 Years
99 Years
ALL
No
Sponsors
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Inflammasome Therapeutics
UNKNOWN
Michelle Abou-Jaoude
OTHER
Responsible Party
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Michelle Abou-Jaoude
Assistant Professor
Principal Investigators
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Michelle Abou-Jaoude, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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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
Countries
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Other Identifiers
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91507
Identifier Type: -
Identifier Source: org_study_id