LUNA

• Research type

  Research Study

• Full title

  A Multi-Center, Randomized, Double-Masked Phase 2 Study to Assess Safety and Efficacy of ADVM-022 (AAV.7m8-aflibercept) in Anti-VEGF Treatment- Experienced Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD) [LUNA]

• IRAS ID

  1006271

• Contact name

  Carla Fiankan

• Contact email

  cfiankan@adverum.com

• Sponsor organisation

  Adverum Biotechnologies, Inc.

• Eudract number

  2022-002261-15

• Research summary

  This clinical study will be evaluating the safety, tolerability, and efficacy of a single intravitreal injection of either a low or high dose of an investigational medicinal product, ADVM-022, in patients with wet age-related macular degeneration. The goal of this clinical study is to determine the appropriate corticosteroid dosing regimen and the appropriate dose of one-time IVT injection of ADVM-022, that together, will allow for the optimum risk benefit profile for the sustained treatment of wet AMD in treatment-experienced patients. During the study period, study participants will be assessed for the need of supplemental aflibercept treatment. The total study duration will be approximately 1 year.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  22/SC/0390

• Date of REC Opinion

  29 Jun 2023

• REC opinion

  Further Information Favourable Opinion