Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03972709

A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD) — GALLEGO  

Geographic Atrophy Clinical Trial

Official title:
A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)

Clinical Trial Summary

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03972709
Study type Interventional
Source Genentech, Inc.
Contact
Status Terminated
Phase Phase 2
Start date June 3, 2019
Completion date October 27, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06161584 - A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Active, not recruiting NCT05536297 - Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy Phase 3
Completed NCT02515942 - CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA) Phase 2
Completed NCT02503332 - Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy Phase 2
Recruiting NCT04339764 - Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT03295877 - Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) Phase 1
Completed NCT01445548 - Sirolimus for Advanced Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00973011 - A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy Phase 1
Terminated NCT02247479 - A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 3
Completed NCT06006585 - A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy Phase 1
Recruiting NCT05961332 - COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy N/A
Terminated NCT02247531 - A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 3
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT01002950 - Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy Phase 2
Completed NCT03777332 - Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy Phase 1
Active, not recruiting NCT04676854 - Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD N/A
Recruiting NCT02372916 - Geographic Atrophy and Intravitreal Ranibizumab Injections N/A
Active, not recruiting NCT05380492 - Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration Phase 1/Phase 2
Terminated NCT04607148 - A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 2
Terminated NCT02087085 - A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration Phase 2