Efficacy and Safety Study of CNTO 2476 in Participants With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)

NCT02895815 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells administered into the subretinal space by the suprachoroidal surgical approach and the subretinal access kit (SRAK-02) in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD).

Conditions

Interventions

COMBINATION_PRODUCT

CNTO 2476 (6.0 * 10^4 cells)

Participants will receive a single subretinal administration of CNTO 2476 (6.0 \* 10\^4 cells) in 50 mcL given by subretinal delivery system (subretinal access kit \[SRAK-02 kit\] and third arm accessory).

COMBINATION_PRODUCT

CNTO 2476 (3.0 * 10^5 cells)

Participants will receive a single subretinal administration of CNTO 2476 (3.0 \* 10\^5 cells) in 50 mcL given by subretinal delivery system (SRAK-02 kit and third arm accessory).

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2021-02-20
Completion
2022-08-19
FDA Drug
Yes

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02895815 on ClinicalTrials.gov