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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. ;


Study Design


Related Conditions & MeSH terms


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

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