A Phase 3 Sham Controlled study of Intravitreal Injections of ANX007 in Patients with GA

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

• IRAS ID

  1010398

• Contact name

  Sibel Boreham

• Contact email

  sboreham@annexonbio.com

• Sponsor organisation

  Annexon, Inc.

• Clinicaltrials.gov Identifier

  NCT06510816

• Research summary

  This is a phase 3, multicenter, randomized, parallel-group, double-masked, 2-Arm, sham controlled study of the efficacy, safety, and tolerability of ANX007 administered by intravitreal (IVT) injection in patients with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). The purpose of this study is to determine if the study drug ANX007 is safe and effective to use in people with GA due to AMD. Other goals are to find out how long the study drug stays in the blood stream and if the study drug produces an immune response (i.e., how the body recognizes and defends itself against substances that appear foreign and harmful (i.e., drug, toxins, viruses, etc.).
  Approximately 630 participants will be enrolled in this study in up to 130 study sites worldwide. This study will be made up of 2 groups:
  • Group 1 = Study drug 5.0 milligrams (mg) in study eye (0.025 millilitres [mL]) every month for 24 months (24 doses)
  • Group 2 = Sham injection every month for 24 months (24 Sham injections)
  The Sham injection is achieved by mimicking all the preparatory steps as with the ANX007 injection, except that instead of injection, the physician is applying pressure to the eye at the location of a typical IVT injection using the blunt end of a syringe without a needle.
  The study will enroll adult (men and women) patients (≥50 years of age) with GA secondary to AMD. It consists of a 30-day screening period and a 24-month double-masked period. Patients will visit the clinic each month during the up to 24-month treatment period for ANX007 or Sham administration and safety assessments.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  24/LO/0841

• Date of REC Opinion

  5 Feb 2025

• REC opinion

  Further Information Favourable Opinion