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NCT02895815 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL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
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
- Visual Acuity
- Geographic Atrophy
- Macular Degeneration
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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