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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 17, 2018

Primary Completion Date

June 25, 2024

Study Completion Date

June 25, 2024

Conditions
Dry Age-related Macular DegenerationMacular DegenerationRetinal DiseaseEye DiseasesRetinal DegenerationGeographic AtrophyMacular Atrophy
Interventions
BIOLOGICAL

GT005

GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI). GT005 was administered as a single time subretinal injection into the study eye of subjects allocated to one of the two GT005 doses.

DEVICE

GT005 / Device: Orbit™ Subretinal Delivery System

"GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI).~A single dose of GT005 was administered with subretinal injection via suprachoroidal cannulation approach.~Device: Orbit™ Subretinal Delivery System"

Trial Locations (13)

19107

Mid-Atlantic Retina, Philadelphia

45242

Cincinnati Eye Institute, Cincinnati

46290

Midwest Eye Institute, Indianapolis

50266

Wolfe Eye Clinic, West Des Moines

63017

Pepose Vision Institute, Chesterfield

89502

Sierra Eye Associates, Reno

02114

Ophthalamic Consultants of Boston (OCB), Boston

Unknown

Bristol Eye Hospital, Bristol

Moorfields Eye Hospital, London

Manchester Eye Hospital, Manchester

Oxford University Hospital, Oxford

Sunderland Eye Infirmary, Sunderland

W1G 7LA

Retina Clinic London, London

Sponsors
All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Gyroscope Therapeutics Limited

INDUSTRY