Actively Recruiting
Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
Led by Luxa Biotechnology, LLC · Updated on 2025-10-15
18
Participants Needed
3
Research Sites
243 weeks
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
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
CONDITIONS
Official 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 age-related macular degeneration (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)
- Female participants must be postmenopausal or female partners of male subjects unable to father children
- Male participants 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 receiving chemotherapy
- Systemic immunosuppressant therapy within the past six months
- History of toxoplasmosis, retinal histoplasmosis, or tuberculosis
- Receipt of investigational product in a clinical trial within prior six months
- Any other medical condition that may interfere with safety, participation, or study results
- Pregnant or nursing females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
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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