NCT04627428 · Luxa Biotechnology, LLC
Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
What this study is about
The main objective of the study is evaluation of the safety and how well patients handle the treatment of RPESC-RPE-4W as therapy for dry AMD.
View original scientific description
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Interventions
BIOLOGICAL
RPESC-RPE-4W
RPESC-RPE-4W
Primary outcome measures
Safety and tolerability of RPESC-RPE-4W transplantation
Time frame: 24 months
The transplantation of RPESC-RPE-4W cells will be considered safe and tolerated in the absence of: * Decrease in visual acuity (VA) of more than 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (or to worse than counting fingers at three feet) from baseline * Any Grade 2 (CTCAE v5.0) or greater non-ocular Adverse Events (AE) related to the RPESC-RPE-4W investigational product (IP) or investigational interventions * Intraocular inflammation indicating contamination with an infectious agent or serious immune response greater than moderate severity related to the RPESC-RPE-4W investigational product or investigational interventions * Tumor formation \> 1 mm size related to the IP or investigational interventions
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Clinical diagnosis of dry AMD. 2. Ability to understand and give informed consent. 3. Adult male or female \>55 years of age. 4. Medically suitable to undergo vitrectomy and subretinal injection (\>60% on Karnofsky scale). 5. Postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children. 6. If male, willing to use barrier and spermicidal contraception during the study.
Exclusion criteria
- Allergy or hypersensitivity to dilation drops or fluorescein. 2. Active major medical conditions limiting ability to participate in the study. 3. Active malignancy or treatment with chemotherapy. 4. Systemic immunosuppressant therapy within past six months. 5. History of toxoplasmosis, retinal histoplasmosis or tuberculosis. 6. Receipt of investigational product (IP) in a clinical trial within prior six months. 7. Any other medical condition, which, in the Investigator's judgment, will interfere w
Where
- Beverly Hills, California
- Palo Alto, California
- Ann Arbor, Michigan
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI), Regenerative Research Foundation, California Institute for Regenerative Medicine (CIRM)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2025 · Source of record for eligibility and locations