Kamuvudine-8 for Age-Related Macular Degeneration

(K8 for GA Trial)

Recruiting at 8 trial locations

Overseen By Clayton Waldridge

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Kentucky

Disqualifiers: Pregnancy, Ocular infections, Glaucoma, others

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

Compensation: Varies

Number of Visits: 8

Duration: 26 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Kamuvudine-8 to determine its safety and effectiveness for people with geographic atrophy (GA), a condition that damages the eye's central area due to age-related macular degeneration (AMD). Participants receive injections in one eye and attend several follow-up visits over 26 weeks to monitor changes in vision and eye health. Ideal participants have AMD with GA and can still read large print. As a Phase 1 trial, this research aims to understand how Kamuvudine-8 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are participating in another clinical study or taking certain investigational drugs, you may need to wait before joining this trial.

Is there any evidence suggesting that Kamuvudine-8 is likely to be safe for humans?

Research shows that Kamuvudine-8 (K8) may help treat geographic atrophy (GA), a type of age-related macular degeneration (AMD). Earlier studies tested K8 for safety in people, and results indicate that it is generally well-tolerated. For instance, one study found positive safety results just three months after a single K8 injection.

Reports have noted reduced growth in GA-affected areas, and the safety data suggests that K8 does not cause major side effects. This is encouraging for those considering joining the trial. Since this study is in its early stages, it focuses on ensuring K8's safety for people. Researchers will closely monitor participants for any side effects. The safety data so far appears promising for potential participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for AMD?

Kamuvudine-8 is unique because it offers a novel approach to treating age-related macular degeneration (AMD), specifically targeting geographic atrophy. Unlike current treatments that mostly focus on slowing disease progression through injections into the eye, Kamuvudine-8 introduces a new active ingredient, which is administered in a small dose directly into one eye. This targeted delivery and the potential for varied dosing options (0.3 mg, 0.7 mg, or 1.05 mg) provide a fresh avenue for managing AMD, potentially offering different outcomes and benefits compared to existing therapies. Researchers are excited about Kamuvudine-8 because it could lead to more personalized and effective treatment options for patients suffering from this vision-impairing condition.

What evidence suggests that Kamuvudine-8 might be an effective treatment for age-related macular degeneration?

Research has shown that Kamuvudine-8 (K8), the investigational treatment in this trial, may help treat geographic atrophy (GA) caused by age-related macular degeneration (AMD). Early findings suggest that K8 can slow the growth of damaged areas in the eye by more than 50%. This treatment blocks certain parts of the immune system that can harm tissue. These initial results offer promise for those seeking new treatment options for GA. ^{1 2 4 5 6}

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 aged 50 or older with geographic atrophy (GA) due to age-related macular degeneration (AMD). Participants must have a certain size of GA lesion, visual acuity of approximately Snellen 20/320 or better, and specific patterns in diagnostic imaging. Those without the required hyperautofluorescence pattern are excluded.

Inclusion Criteria

My eye condition affects only one spot and it's not in the center of my vision.

One of my eye lesions is at least 1.25 mm2 in size.

The size of the geographic atrophy (GA) area in the eye must be between 1 and 8 disk areas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive Kamuvudine-8 treatment via intravitreal injections at baseline and week 13

26 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kamuvudine-8

Trial Overview The study tests the safety and effectiveness of K8, administered through intravitreal injections over a period of 26 weeks. Patients will be monitored through visits and various eye exams to assess changes in vision, GA lesion area, retinal response, reading speed, and microperimetry.

How Is the Trial Designed?

Group I: Patients with geographic atrophy associated with age-related macular degeneration Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

Inflammasome Therapeutics

Collaborator

Trials

3

Recruited

40+

Published Research Related to This Trial

Several promising therapies for age-related macular degeneration (ARMD) are being explored, including stem cells and neurotrophic factors, which may help stabilize or improve vision, although there is currently no cure.

Current clinical trials are investigating a variety of treatments, such as complement inhibitors and anti-amyloid antibodies, while some therapies like eculizumab and vitamin E have not shown effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on current and future novel therapies for dry age-related macular degeneration. Leung, E., Landa, G.[2013]

Emixustat and lampalizumab are two promising new classes of medications being studied for the treatment of dry age-related macular degeneration (AMD), with both showing positive results in phase 2 clinical trials.

Lampalizumab is currently undergoing a large phase 3 clinical trial, focusing on its effectiveness against geographic atrophy, a severe form of dry AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emixustat and Lampalizumab: Potential Therapeutic Options for Geographic Atrophy. Jack, LS., Sadiq, MA., Do, DV., et al.[2018]

Age-related macular degeneration (ARMD) is a major cause of vision loss in individuals over 65, with nearly 30% of those over 75 affected, and its causes include a mix of genetic and environmental factors.

Current treatment options for ARMD, such as pharmacological measures, laser therapy, and surgery, have limited success rates, but low vision aids can significantly enhance the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Age-related macular degeneration (AMD)--therapeutic possibilities and new approaches]. Körner-Stiefbold, U.[2008]

Wet age-related macular degeneration (AMD) is recognized as a complex disease involving not just blood vessel growth but also inflammation, prompting researchers to explore new treatments that target multiple aspects of its pathology.

Several new agents, including VEGF blockers and inflammation inhibitors, are currently in human trials or have been approved, indicating a shift towards more comprehensive treatment strategies for wet AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging pharmacologic therapies for wet age-related macular degeneration. Ni, Z., Hui, P.[2009]

A systematic analysis identified several FDA-approved drugs, including metformin, statins, and antioxidants, that could potentially be repurposed to treat age-related macular degeneration (AMD), particularly for its dry subtype.

The study highlights the use of bioinformatics to discover new therapeutic targets for AMD, suggesting that these findings can guide future preclinical and clinical research in treating this common cause of blindness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Advanced Bioinformatics Tools to Identify Novel Therapeutic Candidates for Age-Related Macular Degeneration. Nadeem, U., Xie, B., Xie, EF., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06164587

NCT06164587 | Evaluation of Kamuvudine-8 in Subjects ... 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 ...

2. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2807545

A Prospective Phase I Clinical Trial of Intravitreal Kamuvudine ... Conclusions : K8 is a novel intervention for GA. Safety and efficacy data for the first 5 patients will be reported for the first time. Early data are promising ...

3. optometrytimes.com optometrytimes.com/view/inflammasome-inhibitor-found-to-reduce-ga-lesion-area-growth-in-clinical-study

Inflammasome inhibitor found to reduce GA lesion area ... The lesion area growth was reduced by more than 50% in its first human clinical trial of K8.

4. ctv.veeva.com ctv.veeva.com/study/evaluation-of-kamuvudine-8-in-subjects-with-geographic-atrophy

Evaluation of Kamuvudine-8 in Subjects With Geographic ... This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in ...

5. synapse.patsnap.com synapse.patsnap.com/article/inflammasome-therapeutics-reports-promising-3-month-clinical-data-for-k8-in-geographic-atrophy

Inflammasome Therapeutics Reports Promising 3-Month ... The K8 implant, therefore, offers a broad-based therapeutic action, effectively reducing lesion growth regardless of different FAF patterns, ...

6. inflam.com inflam.com/images/pdfs-doc/Inflammasome_announces_top_line_3_month_data.pdf

Inflammasome Therapeutics Announces Topline 3-month ... Positive e icacy and safety data were observed at 3 months after a single injection of K8 in this study conducted at the University of Kentucky ...