Recruiting
Phase 1
Phase 2

RPESC-RPE

Sponsor:

Luxa Biotechnology, LLC

Code:

NCT04627428

Conditions

Dry Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

RPESC-RPE-4W

Study Details

Brief summary:

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

Conditions

Dry Age-related Macular Degeneration

Study ID

NCT04627428

Start date

Apr 5, 2022

Status verified date

Oct, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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:

1. 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 with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
8. Pregnant or nursing females.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 50,000 cells

Six patients will receive single dose of 50,000 RPESC-RPE-4W cells in the eye.

experimental: 150,000 cells

Six patients will receive single dose of 150,000 RPESC-RPE-4W cells in the eye.

experimental: 250,000 cells

Six patients will receive single dose of 250,000 RPESC-RPE-4W cells in the eye.

Interventions

RPESC-RPE-4W

RPESC-RPE-4W

Primary outcome measure

  • Safety and tolerability of RPESC-RPE-4W transplantation [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Jeffrey H Stern, M.D., Ph.D.

05184371111jeffreystern@luxabiotech.com

Locations

Retina Vitreous Associates Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Spencer Center for Vision Research

Recruiting

Palo Alto, California, United States, 94303

University of Michigan Kellogg Eye Center

Recruiting

Ann Arbor, Michigan, United States, 48105

More Information

Sponsor

Luxa Biotechnology, LLC

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Luxa Biotechnology, LLC on 2025-10-15.