Derby - Geographic Atrophy secondary to AMD

• Research type

  Research Study

• Full title

  A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD).

• IRAS ID

  248847

• Contact name

  Ramiro Ribeiro

• Contact email

  ramiro@apellis.com

• Sponsor organisation

  Apellis Pharmaceuticals

• Eudract number

  2018-001436-22

• Clinicaltrials.gov Identifier

  NCT03525600

• Clinicaltrials.gov Identifier

  OPHT 39165, NIHR CRN - CPMS ID

• Duration of Study in the UK

  2 years, 10 months, 12 days

• Research summary

  This study is designed to obtain information on the safety, tolerability and the effectiveness of an experimental drug called APL-2 when it is given as an intravitreal injection (into the inside of the eye) to patients to treat Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).

  Currently, there is no effective treatment available for Geographic Atrophy secondary to Age-related Macular Degeneration. Patients with GA generally develop a round area of cells called a lesion that can lead to vision loss. The study is being done to see if APL-2 may be able to slow down growth of the GA lesion.

  Approximately 600 participants from 100 medical centres globally, are expected to take part. In the UK, it is expected that approximately 16-20 patients will be enrolled from 3 participating centres.
  To participate in the study, participants must be diagnosed with GA of the macula, secondary to AMD, in one or both eyes. The study will enrol male and female subjects aged 60 years of age and above.

  Participants who qualify for the study and choose to participate, will be randomly assigned to receive either the experimental drug or sham injection. Participants will be asked to remain in the study for approximately 31 months. After completion of the 24 month treatment period, participants will be offered participation in an open-label extension study.
  Study procedures include: collection of medical history, vital signs, physical examination, complete ophthalmologic examination, ocular imaging, and questionnaires completion. This study is sponsored by Apellis Pharmaceuticals, Inc.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  18/NW/0694

• Date of REC Opinion

  7 Dec 2018

• REC opinion

  Further Information Favourable Opinion