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Geographic AtrophyPhase 1/2K8 for GANCT06164587

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

A Phase 1/2 study testing K8 in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Inflammasome Therapeutics at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 99 years
What is being tested?
K8
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
9 sitesUnited States
Study dates
18 Apr 2024to 15 May 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 Exclusion Criteria:
  • 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

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Southeastern Retina Associates

    Bristol, Virginia, 24201

  • Oregon Eye Consultants, Cascade Medical Research

    Eugene, Oregon, 97401

  • Hilton Head Retina Institute

    Hilton Head, South Carolina, 29926-2277

  • Southeastern Retina Associates

    Hixson, Tennessee, 37343

  • University of Kentucky Advanced Eye Care

    Lexington, Kentucky, 40508

  • Loma Linda University

    Loma Linda, California, 92354

  • The Maine Eye Center

    Portland, Maine, 04101

  • Vistar Eye Center

    Roanoke, Virginia, 24019

  • Ophthalmology LTD

    Sioux Falls, South Dakota, 57108

Other trials in United States

About this study

Official title: A Non-Randomized, Open Label, Safety and Efficacy Study Evaluating Kamuvudine-8 (K8) for the Treatment of Patients With Geographic Atrophy

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.

Being tested
K8
Keywords
ophthalmology, K8, kamuvudine
Medical subject headings
Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • K8Drug

    Also called SOM-401

    sustained released bio-erodible intravitreal implants

Study groups in NCT06164587
Study groupRoleWhat they receive
Patients with geographic atrophy associated with age-related macular degenerationExperimentalKamuvudine-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.
Receives: Drug: K8

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Frequency of participants experiencing ocular or systemic adverse events.

    Measured: Within the study period (of 26 weeks)

  2. 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)

    Measured: At baseline visit, week 13 visit, and week 26 visit

  3. Mean change in low-luminance best-corrected visual acuity (ll-BCVA)

    best-corrected visual acuity in low-lighting settings

    Measured: At baseline visit, week 13 visit, and week 26 visit

  4. 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

    Measured: At baseline visit, week 13 visit, and week 26 visit

  5. 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

    Measured: At baseline visit, week 13 visit, and week 26 visit

  6. change in size of geographic atrophy (GA) on fluorescein angiogram (FA)

    Change in total area of geographic atrophy lesions as analyzed with FA imaging

    Measured: At baseline visit, week 13 visit, and week 26 visit

  7. 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

    Measured: At baseline visit, week 13 visit, and week 26 visit

  8. 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).

    Measured: At baseline visit, week 13 visit, and week 26 visit

  9. Change in reading speed

    Change in reading speed as measured by Radner reading chart procedure

    Measured: At baseline visit, week 13 visit, and week 26 visit

  10. Discontinued subjects

    Number of subjects exiting study for any reason

    Measured: This will be done at every scheduled visit and any unscheduled visit, as well as when reported by participants (for 26 weeks)

Secondary outcomes (1)

  1. Change in best corrected visual acuity (BCVA) over multiple time points

    Change in best corrected visual acuity (BCVA) at each study visit

    Measured: Day 2 visit, Week 4 visit, Week 13 visit, Week 13 + 2 Days visit, and Week 17 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start18 Apr 2024
  3. Primary completion15 May 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06164587
Sponsor's protocol ID
91507
Acronym
K8 for GA
Status last verified
Jul 2026
First submitted
1 Dec 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing K8 in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Inflammasome Therapeutics at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Within the study period (of 26 weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06164587.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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