Kamuvudine-9 for Diabetic Macular Edema

Overseen By Mary C Crutchfield, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Michelle Abou-Jaoude

Must be taking: Insulin, Oral hypoglycemics

Must not be taking: Anti-VEGF, Steroids

Disqualifiers: Pregnancy, Recent ocular surgery, Severe foveal ischemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new oral treatment called Kamuvudine-9 for individuals with diabetic macular edema (DME), a condition where fluid accumulates in the eye due to diabetes, leading to vision problems. Participants will take tablets twice daily for 24 weeks to assess their eyes' response. Ideal candidates for this trial have type 1 or type 2 diabetes with DME and have not recently undergone eye surgeries or certain treatments for their condition. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic steroidal therapy, it should not have changed within 3 months of screening. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that Kamuvudine-9 is likely to be safe for humans?

Research has shown that Kamuvudine-9, or K9, is being tested for safety in treating diabetic macular edema (DME). In these studies, patients took K9 as a pill twice a day, focusing on how well individuals tolerated the drug and any side effects experienced.

The current trial is in its early stages, marking the first time the treatment is tested for safety in humans. Researchers closely monitor any side effects during these initial trials. As an early trial, detailed safety information may be limited, but these studies aim to identify safety issues promptly.

Other studies have shown that Kamuvudine-9 protects the retina, the light-sensitive part at the back of the eye. This finding offers hope for its safety in eye conditions like DME. However, further research is necessary to confirm its safety in humans. Participants in the trial will help researchers gather this crucial information. ^{1 2 3 4 5}

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

Unlike the standard treatments for diabetic macular edema, which often involve injections or laser therapy, Kamuvudine-9 offers a new approach by using oral tablets. This treatment works through a unique mechanism, targeting inflammation pathways that are crucial in the development of diabetic macular edema. Researchers are excited about Kamuvudine-9 because it could potentially provide a more convenient and less invasive option, improving patient comfort and adherence to treatment.

What evidence suggests that Kamuvudine-9 might be an effective treatment for diabetic macular edema?

Research has shown that Kamuvudine-9, or K9, offers promising results for eye health. Early studies demonstrated that K9 helped with conditions like diabetic macular edema (DME), which causes swelling in the retina. This trial will evaluate K9's effects on reducing this swelling. Additionally, similar oral treatments have improved vision clarity in DME patients. These findings provide hope that Kamuvudine-9 could protect the retina and improve vision in people with diabetic macular edema. ^{5 6 7 8 9}

Who Is on the Research Team?

Michelle Abou-Jaoude, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with Diabetic Macular Edema (DME), a condition where fluid accumulates in the retina due to diabetes, causing swelling and vision problems. Specific eligibility criteria are not provided.

Inclusion Criteria

BCVA of ≥ 24 and ≤ 68 letters (20/50 or worse but at least 20/320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20/400 Snellen equivalent

I have diabetes with a specific eye condition but not severe retinopathy.

Ability to understand and sign the informed consent form

Exclusion Criteria

I have had eye infections or diseases caused by viruses, bacteria, or fungi.

I haven't had eye surgery in the last 12 weeks.

I have had eye treatments for DME within the allowed time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive 96 mg tablets of K9 twice a day for 4 weeks

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Kamuvudine-9

Trial Overview The study is testing K9, an orally taken medication that aims to reduce inflammation in the eye. It's a non-randomized trial, meaning all participants will receive K9 without being compared to a placebo or other treatment.

How Is the Trial Designed?

Group I: Subjects with DME Experimental Treatment 1 Intervention

Patients will receive a regimen of 96 mg tablets of K9 to be taken twice a day for 24 weeks.

Who Is Running the Clinical Trial?

Michelle Abou-Jaoude

Lead Sponsor

Trials

2

Recruited

6+

Inflammasome Therapeutics, Inc.

Collaborator

Trials

1

Recruited

5+

Citations

1. researchgate.net researchgate.net/publication/370470088_Kamuvudine-9_Protects_Retinal_Structure_and_Function_in_a_Novel_Model_of_Experimental_Rhegmatogenous_Retinal_Detachment

Kamuvudine-9 Protects Retinal Structure and Function in a ... An interim therapy protecting photoreceptors could improve functional outcomes. We sought to determine whether Kamuvudine-9 (K-9), a derivative ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666634025001746

Oral lamivudine in diabetic macular edema: A randomized, ... This randomized, double-blind, placebo-controlled trial compared oral lamivudine to placebo for improving visual acuity in center-involved DME (CI-DME).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11642061/

Real-World Outcomes of Different Types of Treatment for ... The object of this study was to determine the outcomes of treatments other than anti-vascular endothelial growth factor (VEGF) therapy for diabetic macular ...

4. cell.com cell.com/med/abstract/S2666-6340(25)00174-6

Oral lamivudine in diabetic macular edema: A randomized, ... Secondary outcomes included retinal thickness and adverse events. Findings. At 4 weeks, BCVA improved 9.8 letters with lamivudine and decreased 1.8 letters with ...

5. synapse.patsnap.com synapse.patsnap.com/organization/35b9967259034b970cce897a44c265ff

Inflammasome Therapeutics, Inc. - Drug pipelines, Patents, ... “ Preclinical data show impressive efficacy of Kamuvudine K9 in multiple neurodegeneration models,” said Dr, Ambati. Oral K9 is currently being ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06781255

Evaluation of K9 in Subjects With Diabetic Macular Edema ... A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME). Detailed ...

7. ctv.veeva.com ctv.veeva.com/study/evaluation-of-k9-in-subjects-with-diabetic-macular-edema-dme

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.

8. go.drugbank.com go.drugbank.com/conditions/DBCOND0060562

Diabetic Macular Edema (DME) (DBCOND0060562) A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe.

9. synapse.patsnap.com synapse.patsnap.com/drug/ea6b0debfc464d7580c3dddc7fae85ab

Kamuvudine-9 - Drug Targets, Indications, Patents Kamuvudine-9 protects retinal structure and function in a novel model of experimental rhegmatogenous retinal detachment.