EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 — EXPLORE  

Dry Age-related Macular Degeneration Clinical Trial

Official title: EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

Status Active, not recruiting

Clinical Trial Summary

The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

Clinical Trial Description

This is a Phase 2, outcomes assessor-masked, multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.

The trial includes a screening period of up to 8 weeks followed by a 96-week study period.

Subjects will be randomised to one of two arms: GT005 or the untreated control group.

Part 1 is conducted in a genetically selective sub-group of patients with GA secondary to AMD.

Part 2 is conducted in a non-genetically selective sub-group of patients with GA secondary to AMD.

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

• Dry Age-related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

• NCT number: NCT04437368
• Study type: Interventional
• Source: Gyroscope Therapeutics Limited
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 14, 2020
• Completion date: March 29, 2024