NCT02659098

A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy

A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.

Detailed description

This is a multicenter (when more than one hospital or medical school team work on a medical research study) study which includes an initial unmasked safety phase. The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be monitored throughout the study.

Conditions

• Visual Acuity
• Geographic Atrophy
• Macular Degeneration

Interventions

Type	Name	Description
DRUG	CNTO 2476 3.0 x 10^5 cells	Participants will receive a single subretinal administration of CNTO 2476 3.0 x 10\^5 cells in 50 microliter (mcL) given by subretinal Delivery System.
DEVICE	Subretinal Delivery System	Participants will receive CNTO 2476 by using the Delivery System.

Timeline

• Start date: 2015-12-04
• Primary completion: 2019-06-05
• Completion: 2019-06-05
• First posted: 2016-01-20
• Last updated: 2025-04-29
• Results posted: 2020-06-23

Locations

8 sites across 1 country: United States