Kamuvudine-9 for Diabetic Macular Edema

(K9 Trial)

Overseen By Bryan Strelow, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Dr. Bryan Strelow

Must be taking: Insulin, Hypoglycemic agents

Must not be taking: NRTIs, Retinal toxicity drugs

Disqualifiers: Pregnancy, Active cancer, Severe liver/kidney issues, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called Kamuvudine K9 to determine its safety and effectiveness for people with diabetic macular edema (DME), a condition that can cause vision problems. The study aims to discover if Kamuvudine K9 improves vision more effectively than a placebo (a pill with no active medicine). Participants will join one of two groups: one taking Kamuvudine K9 and the other taking a placebo. The trial seeks individuals diagnosed with DME due to diabetes who have noticeable vision impairment in at least one eye. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group of people, offering participants a chance to be among the first to benefit from this potential new therapy.

Is there any evidence suggesting that Kamuvudine K9 is likely to be safe for humans?

Research has shown that Kamuvudine K9 (K9) underwent safety testing in earlier studies. In one study, five patients with diabetic macular edema (DME) took K9 orally twice a day for 28 weeks. This study focused on safety and did not find any serious side effects. Another study examined the safety of K9 for brain and eye conditions. These studies suggest that K9 is generally safe, but further research is necessary for confirmation. Prospective trial participants may find this information helpful in understanding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic macular edema?

Kamuvudine K9 is unique because it targets diabetic macular edema in a novel way. Unlike current treatments, which mainly focus on reducing inflammation and fluid leakage using injections or laser therapy, Kamuvudine K9 is administered orally through tablets. This new approach could greatly simplify treatment for patients, making it more accessible and less invasive. Researchers are excited because Kamuvudine K9 has the potential to offer a more convenient and less painful option, while possibly enhancing patient adherence to treatment.

What evidence suggests that Kamuvudine K9 might be an effective treatment for Diabetic Macular Edema?

Research has shown that Kamuvudine-9 (K9) might help treat diabetic macular edema (DME), a condition affecting vision. Early studies suggest that K9 can enhance retinal function, crucial for clear vision. K9 achieves this by blocking specific immune system components that cause harmful inflammation in the eye. This action may protect the retina and improve vision. In this trial, participants will receive either Kamuvudine-9 or a placebo to further evaluate its effectiveness. Although more research is necessary, these early results offer promise for people with DME. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Best-corrected visual acuity (BCVA) of ≥ 24 and ≤ 68 letters (20/50 or worse but at least 20/320) by an ETDRS chart

I am able to understand and agree to participate in the study.

I agree to use birth control or abstain from sex during and after the study.

Exclusion Criteria

I do not have any health conditions that would prevent me from joining or completing the study.

I have cancer now or have had cancer in the past.

I have an eye condition that makes it hard to see my retina.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Kamuvudine-9 or placebo tablets twice daily

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kamuvudine K9

How Is the Trial Designed?

Group I: Kamuvudine Group 2 Experimental Treatment 1 Intervention

Kamuvudine tablets BID

Group II: Placebo Group 1 Placebo Group 1 Intervention

Placebo tablets

Who Is Running the Clinical Trial?

Dr. Bryan Strelow

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07458061

Kamuvudine-9 (K9) in Diabetic Macular Edema

The objectives of this investigation are to assess: whether oral K9 is safe in subjects with DME, and; whether oral K9 improves BCVA compared to oral ...

2.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT06781255/

Trial | NCT06781255

A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME).

3.

trial.medpath.com

trial.medpath.com/clinical-trial/b5e3a70c34f208a7/nct06781255-k9-diabetic-macular-edema-dme-evaluation

Evaluation of K9 in Subjects With Diabetic Macular Edema ...

This is an twenty-eight (28) week non-randomized, open-label, safety study evaluating twice daily, oral K9 in five (5) patients. Subjects with DME meeting ...

4.

hipa.ai

hipa.ai/study/NCT07458061

Kamuvudine-9 (K9) in Diabetic Macular Edema

The objectives of this investigation are to assess: 1. whether oral K9 is safe in subjects with DME, and 2. whether oral K9 improves BCVA compared to oral …

5.

ophthalmologymanagement.com

ophthalmologymanagement.com/news/2025/inflammasome-therapeutics-investigational-drug-slows-ga-progression/

Inflammasome Therapeutics Investigational Drug Slows ...

Inflammasome Therapeutics reports that K8 slowed the rate of lesion growth by more than 50% at 3 months in an early trial. Ophthalmology ...

6.

modernretina.com

modernretina.com/view/inflammasome-therapeutics-completes-enrollment-of-phase-i-pk-safety-for-k9

Inflammasome Therapeutics completes enrollment of ...

Inflammasome Therapeutics has completed enrollment of a Phase I PK/Safety study of its new brain- and retina-penetrant drug, K9.