Kamuvudine-8 for Age-Related Macular Degeneration

(K8 for GA Trial)

Recruiting at 4 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

Trial Summary

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.

What makes the drug Kamuvudine-8 unique for treating age-related macular degeneration?

Kamuvudine-8 is unique because it is being explored as a potential treatment for age-related macular degeneration, a condition for which there are currently no standard drug treatments available, especially for the dry form of the disease. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Michelle Abou-Jaoude, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 5 subjects. 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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using Advanced Bioinformatics Tools to Identify Novel Therapeutic Candidates for Age-Related Macular Degeneration. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Update on current and future novel therapies for dry age-related macular degeneration. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Emixustat and Lampalizumab: Potential Therapeutic Options for Geographic Atrophy. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Emerging pharmacologic therapies for wet age-related macular degeneration. [2009]