Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
Recruiting now · Phase 1/Phase 2
Conditions studied: Dry Age-related Macular Degeneration
In brief
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Key facts
- Study ID
- NCT04627428
- Run by
- Luxa Biotechnology, LLC
- People needed
- 18
- Starts
- 2022-04-05
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-10-15
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical diagnosis of dry AMD.
- Ability to understand and give informed consent.
- Adult male or female >55 years of age.
- Medically suitable to undergo vitrectomy and subretinal injection (>60% on Karnofsky scale).
- Postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children.
- If male, willing to use barrier and spermicidal contraception during the study.
You may not qualify if…
- Allergy or hypersensitivity to dilation drops or fluorescein.
- Active major medical conditions limiting ability to participate in the study.
- Active malignancy or treatment with chemotherapy.
- Systemic immunosuppressant therapy within past six months.
- History of toxoplasmosis, retinal histoplasmosis or tuberculosis.
- Receipt of investigational product (IP) in a clinical trial within prior six months.
- Any other medical condition, which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
- Pregnant or nursing females.
Where it is running
- Retina Vitreous Associates Medical Group — Beverly Hills, California, United States (enrolling)
- Spencer Center for Vision Research — Palo Alto, California, United States (enrolling)
- University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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