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Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy (K8 for GA)

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ClinicalTrials.gov Identifier: NCT06164587
Recruitment Status : Recruiting
First Posted : December 11, 2023
Last Update Posted : April 23, 2024
Sponsor:
Collaborator:
Inflammasome Therapeutics
Information provided by (Responsible Party):
Michelle Abou-Jaoude, University of Kentucky

Study Description
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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.

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.


Condition or disease Intervention/treatment Phase
Geographic Atrophy Age-Related Macular Degeneration Drug: K8 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-Randomized, Open Label, Safety and Efficacy Study Evaluating Kamuvudine-8 (K8) for the Treatment of Patients With Geographic Atrophy
Actual Study Start Date : April 18, 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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 5 subjects. Patients will be followed for 26 weeks after baseline visit injection.
 Drug: K8
sustained released intravitreal implants
Other Name: SOM-401


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Within the study period (of 26 weeks) ]
    Frequency of participants experiencing ocular or systemic adverse events.

  2. Mean change in best-corrected visual acuity (BCVA) [ Time Frame: At baseline 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)

  3. Mean change in low-luminance best-corrected visual acuity (ll-BCVA) [ Time Frame: At baseline visit and week 26 visit ]
    best-corrected visual acuity in low-lighting settings

  4. Change in size of geographic atrophy (GA) on fundus autofluorescence (FAF) [ Time Frame: At baseline visit and week 26 visit ]
    Change in total area of geographic atrophy lesions as analyzed with FAF imaging over the course of the trial

  5. change in size of geographic atrophy (GA) on optical coherence tomography (OCT) [ Time Frame: At baseline visit and week 26 visit ]
    Change in total area of geographic atrophy lesions as analyzed with OCT imaging

  6. change in size of geographic atrophy (GA) on fluorescein angiogram (FA) [ Time Frame: At baseline visit and week 26 visit ]
    Change in total area of geographic atrophy lesions as analyzed with FA imaging

  7. Change in multifocal electroretinograms (mfERG) response [ Time Frame: At baseline visit, week 13 visit, and week 26 visit ]
    Total response change measured by mfERG, which measures the electrical signal generated by a functionining eye processing information

  8. Change in microperimetry response [ Time Frame: 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.

  9. Change in reading speed [ Time Frame: At baseline visit, week 13 visit, and week 26 visit ]
    Change in reading speed as measured by Radner reading chart procedure

  10. Discontinued subjects [ Time Frame: 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 Outcome Measures :
  1. Change in best corrected visual acuity (BCVA) over multiple time points [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:
  • Total geographic atrophy (GA) area 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:

  • 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 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 age-related macular degeneration (AMD) that may confound results
  • Known hypersensitivity to study drug or any of the excipients in implant.
  • Macular atrophy secondary to a condition other than age-related macular degeneration (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.
  • 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 either eye including topical, IVT, subretinal, suprachoroidal, periocular or oral medication or placebo within the last 6 weeks or 5 half-lives of the active ingredient (whichever is longer).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06164587


Contacts
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Contact: Sara Kuhl 859-562-3570 sara.kuhl@uky.edu
Contact: Connie Dampier 8595620750 dampier@email.uky.edu

Locations
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United States, Kentucky
University of Kentucky Advanced Eye Care Recruiting
Lexington, Kentucky, United States, 40508
Sponsors and Collaborators
University of Kentucky
Inflammasome Therapeutics
Investigators
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Principal Investigator: Michelle Abou-Jaoude, MD University of Kentucky
More Information
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Responsible Party: Michelle Abou-Jaoude, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT06164587    
Other Study ID Numbers: 91507
First Posted: December 11, 2023    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Abou-Jaoude, University of Kentucky:
ophthalmology
K8
kamuvudine
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical