Kamuvudine-8 for Age-Related Macular Degeneration
(K8 for GA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Kentucky
Disqualifiers: Pregnancy, Ocular infections, Glaucoma, others
No Placebo Group
Trial Summary
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.
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.
12345Eligibility 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.
+4 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Patients with geographic atrophy associated with age-related macular degenerationExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Kentucky Advanced Eye CareLexington, KY
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Who Is Running the Clinical Trial?
University of KentuckyLead Sponsor
Inflammasome TherapeuticsCollaborator
References
Using Advanced Bioinformatics Tools to Identify Novel Therapeutic Candidates for Age-Related Macular Degeneration. [2022]Age-related macular degeneration (AMD) is the most common cause of aging-related blindness in the developing world. Although medications can slow progressive wet AMD, currently, no drugs to treat dry-AMD are available. We use a systems or in silico biology analysis to identify chemicals and drugs approved by the Food and Drug Administration for other indications that can be used to treat and prevent AMD.
Update on current and future novel therapies for dry age-related macular degeneration. [2013]Age-related macular degeneration (ARMD) is the leading cause of irreversible blindness in developed countries. There are currently no cures, but there are promising potential therapies that target the underlying disease mechanisms of dry ARMD. Stem cells, ciliary neurotrophic factor, rheopheresis, ozonated autohemotherapy and prostaglandins show promise in stabilizing or improving visual acuity. Age-Related Eye Disease Study vitamins may reduce progression to severe ARMD. Adjuvant therapy like low vision rehabilitation and implantable miniature telescopes may help patients adjust to the sequelae of their disease, and herbal supplementation with saffron, zinc monocysteine and phototrop may be helpful. Therapies that are currently in clinical trials include brimonidine, doxycycline, anti-amyloid antibodies (GSK933776 and RN6G), RPE65 inhibitor (ACU-4429), complement inhibitors (ARC1905, FCFD4514S), hydroxychloroquine, intravitreal fluocinolone acetate and vasodilators like sildenafil, moxaverine and MC-1101. Therapies that have not been shown to be effective include POT-4, eculizumab, tandospirone, anecortave acetate, the antioxidant OT-551, sirolimus and vitamin E.
[Age-related macular degeneration (AMD)--therapeutic possibilities and new approaches]. [2008]Age related macular degeneration (ARMD) is one of the leading causes of irreversible vision loss in patients over 65 years of age. Nearly 30 percent of persons over 75 years of age will suffer from ARMD. The etiology is not yet fully understood. Besides age, many risk factors such as gender, arterial hypertension, arteriolosclerosis, elevated serum lipids, smoking, alcohol abusus, and exposure to UV light are being discussed. Genetic factors are certainly involved as well; familiar predisposition is assumed in more than 50 percent of cases. White individuals are more affected than colored ones. Predisposing ocular signs are macular drusen, focal hyperpigmentation, and light eyes. In this review, anatomical, pathophysiological and fluorescein-angiographic features and the clinical classification of exudative and dry stages of ARMD are described. Concepts of management of ARMD include pharmacological measures, laser treatment, photodynamic therapy, and surgery including excision of submacular choroidal neovascular membranes and macular translocation. Success rates of any therapeutic method are very limited. Low vision aids are promising by improving quality of life in many cases.
Emixustat and Lampalizumab: Potential Therapeutic Options for Geographic Atrophy. [2018]Two novel classes of medications are currently under extensive investigation for the treatment of dry age-related macular degeneration (AMD). Emixustat, an orally administered visual cycle inhibitor, and lampalizumab, an intravitreally administered monoclonal body directed against complement factor D, have shown promise in phase 2 clinical trials in the treatment of nonneovascular (dry) AMD. Lampalizumab is currently being evaluated in a large, multicenter, phase 3 clinical trial for dry AMD - geographic atrophy.
Emerging pharmacologic therapies for wet age-related macular degeneration. [2009]As researchers and clinicians are beginning to understand that wet age-related macular degeneration (AMD) is more than simply a vascular disease that includes angiogenic, vascular and inflammatory components, they are exploring new agents with different mechanisms of action addressing multiple targets in this complex pathophysiology. Some of them are already available in human trials or even approved vascular epithelial growth factor (VEGF) blockers such as Macugen, Lucentis, Avastin, VEGF Trap-Eye and Cand5; VEGF receptor blockers such as TG100801, vatalanib, pazopanib, Sirna-027 and a vaccine approach; inflammation inhibitors and immunosuppressants such as Retaane, Kenalog, ARC1905, POT-4, OT-551. The last group is mixed, containing agents such as Zybrestat, AdPEGF, Sirolimus, JSM6427, ATG003, E10030. This article reviews these currently emerging agents and briefly discusses the next step for the treatment of wet AMD.