FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD

Macular Degeneration Clinical Trial

Official title: FOCUS: An Open Label First in Human Phase I/II Multicentre Study to Evaluate the Safety, Dose Response and Efficacy of GT005 Administered as a Single Subretinal Injection in Subjects With Macular Atrophy Due to AMD

Status Active, not recruiting

Clinical Trial Summary

This is an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to AMD

Clinical Trial Description

This study will evaluate the safety, the dose response and efficacy (anatomical and functional visual outcomes) of three doses of GT005 administered as a single subretinal injection in genetically defined subjects with Macular Atrophy due to Age-related Macular Degeneration (AMD). Following consent, subjects will undergo a number of ophthalmic and clinical assessments to determine eligibility for inclusion in the study. Once eligibility is confirmed, subjects will be enrolled, receive treatment, and will be followed for 48 weeks, with the option to be followed for a further 4 years in long-term follow up after completing week 48.

This study is terminating early due to the interim analysis demonstrating lack of treatment efficacy. No additional subjects will be randomized or dosed. The trial is not ending early because of medical problems. ;

Related Conditions & MeSH terms

• Atrophy
• Dry Age-related Macular Degeneration
• Eye Diseases
• Geographic Atrophy
• Macular Atrophy
• Macular Degeneration
• Retinal Degeneration
• Retinal Disease
• Retinal Diseases

• NCT number: NCT03846193
• Study type: Interventional
• Source: Gyroscope Therapeutics Limited
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: December 17, 2018
• Completion date: June 28, 2024