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Bored Studies
RecruitingPhase 1/Phase 2

Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)

Luxa Biotechnology, LLC · with National Institutes of Health (NIH), National Eye Institute (NEI) · NCT04627428

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
18
US sites recruiting
3
Study start
April 5, 2022
Record last updated
October 15, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.

Being studied: RPESC-RPE-4W

Conditions: Dry Age-related Macular Degeneration

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Recruiting US locations

  • Retina Vitreous Associates Medical Group

    Beverly Hills, CA 90211

    Site contact: David S Liao, MD, PhD

  • Spencer Center for Vision Research

    Palo Alto, CA 94303

    Site contact: Theodore Leng, MD, FACS

  • University of Michigan Kellogg Eye Center

    Ann Arbor, MI 48105

    Site contact: Rajesh C Rao, M.D.

Study contacts (from the official record)

  • Jeffrey H Stern, M.D., Ph.D. · 05184371111 · jeffreystern@luxabiotech.com
All phase 1 studies in California →
Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE)… (NCT04627428) | Bored Studies