Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD

A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02467634

Acronym

RADIANT

Enrollment

Registered

2015-06-10

Start date

2015-06-30

Completion date

2016-05-31

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Brief summary

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.

Detailed description

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.

Interventions

BIOLOGICALHuCNS-SC sub-retinal transplantation

HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Inclusion criteria

* GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence. * BCVA of 20/320 or better in each eye at screening assessment

Exclusion criteria

* Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center. * Retinal or macular disease of any other cause in either eye. * Diagnosis of glaucoma in either eye. * Uncontrolled intraocular pressure in either eye * Compromised renal function defined as eGFR \<60mL/min and urine protein-to-creatinine ration \>0.3 is spot urine collection. * History of or active autoimmune disease. * Previous organ, tissue or bone marrow transplantation. * Seropositive for HIV, hepatitis B or C, or CMV IgM

Design outcomes

Primary

Measure	Time frame
GA area based on fundus autofluorescence	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026