Actively Recruiting
Safety and Tolerability of RPE Stem Cell-derived RPE Transplantation as Therapy for Dry Age-related Macular Degeneration (AMD)
Led by Luxa Biotechnology, LLC · Updated on 2025-10-15
18
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Luxa Biotechnology, LLC
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a new therapy called RPESC-RPE-4W, which involves transplanting stem cell-derived retinal pigment epithelial (RPE) cells to treat dry age-related macular degeneration (AMD). This first-in-human Phase 1/2a open-label study aims to enroll 18 adults with dry AMD to assess this treatment. The study is sponsored by Luxa Biotechnology, LLC and focuses on monitoring safety and visual function over time. Participants will receive a single dose of RPESC-RPE-4W cells transplanted under the macular area of the eye. There are three groups in this study, each receiving a different dose: 50,000 cells, 150,000 cells, or 250,000 cells. The study is non-randomized and open-label, meaning both researchers and participants know which dose is administered. During the 24-month study period, participants will undergo regular assessments including measurements of best corrected visual acuity, visual sensitivity using microperimetry, and changes in geographic atrophy lesion area. Researchers will also look for structural changes in the retina. Safety monitoring will be ongoing to evaluate the tolerability of the transplanted cells. Participants will be followed for two years to assess both safety and potential changes in vision.
CONDITIONS
Brief Title
Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of dry AMD
- Ability to understand and give informed consent
- Adult male or female over 55 years of age
- Medically suitable to undergo vitrectomy and subretinal injection (over 60% on Karnofsky scale)
- Postmenopausal if female, or female partner of a male unable to father children
- If male, willing to use barrier and spermicidal contraception during the study
You will not qualify if you...
- Allergy or hypersensitivity to dilation drops or fluorescein
- Active major medical conditions limiting ability to participate
- Active malignancy or recent chemotherapy treatment
- Systemic immunosuppressant therapy within past six months
- History of toxoplasmosis, retinal histoplasmosis, or tuberculosis
- Receipt of investigational product in clinical trial within prior six months
- Any medical condition interfering with protocol compliance or safety
- Pregnant or nursing females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with follow-up over 24 months
Participants receive a single dose of RPESC-RPE-4W cells transplanted under the macula to treat dry age-related macular degeneration.
Multiple visits for assessments during 24 months following treatment
Duration - Up to 24 months
Participants are monitored for safety, tolerability, and changes in visual function and retinal structure for up to 24 months after treatment.
Regular follow-up visits during 24 months post-treatment
Trial Site Locations
Total: 3 locations
1
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Spencer Center for Vision Research
Palo Alto, California, United States, 94303
Actively Recruiting
3
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
Research Team
J
Jeffrey H Stern, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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