Clinical Trials Logo
  1. Home
  2. Geographic Atrophy
  3. NCT02503332

Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy — FILLY  

Geographic Atrophy Clinical Trial

Official title:
A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients With Geographic Atrophy (GA)

Clinical Trial Summary

The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of pegcetacoplan in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).

Clinical Trial Description

This is a Phase II, prospective, multicenter, randomized, single-masked, sham-controlled study to assess the safety, tolerability and evidence of activity of multiple IVT injections of pegcetacoplan in subjects with GA secondary to Age-Related Macular Degeneration.

The study will randomize approximately 240 subjects to obtain at least 200 evaluable subjects across 40 multinational sites.

Subjects will be randomized in a 2:2:1:1 manner to receive pegcetacoplan Monthly (AM), pegcetacoplan Every-Other-Month (AEOM), Sham injection Monthly (SM) or Sham injection Every-Other-Month (SEOM), respectively.

All subjects will return to the clinical site on Day 7 to assess acute safety after the first injection. After that, subjects in the monthly groups will return to the clinical site for additional pegcetacoplan (or Sham) injections and study procedures every month until Month 12. Subjects in the Every-Other-Month groups will return to the clinical site for additional pegcetacoplan (or Sham) injections and study procedures every two months until Month 12. All subjects will return for follow-up visits on Months 15 and 18 (3 and 6 months after last injection, respectively). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02503332
Study type Interventional
Source Apellis Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date September 24, 2015
Completion date January 17, 2018
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
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
Active, not recruiting 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
Active, not recruiting NCT03845582 - Phase 3 Study of ALK-001 in Geographic Atrophy Phase 3