Case study

01 Feb 2021

Neovascular AMD (age related macular degeneration)


Overview

A phase 3 combination study investigating the safety and efficacy of intravenous injection of IMP or sham administered in subjects with subfoveal neovascular AMD. The sponsor was a small US biotech developing innovative treatments for patients with orphan or inherited retinal diseases with significant unmet medical needs.

  • Study Phase: III
  • Indication: Neovascular AMD (age related macular degeneration)
  • Number of patents: 622
  • Sites: 226
  • Services: Feasibility/site qualification, start-up (including site contracts/submissions, certifications), site management, project management and TMF


Challenges

  • The sponsor instigated numerous strategic changes during the life of the study, including a significant expansion of 16 new countries, which triggered rapid changes in TFS’ management and delivery strategy.
  • This was a complicated study to enroll, mainly due to baseline and Day 1 visual acuity needs, resulting in a 50% screen failure rate, which led to a very slow and lengthy enrollment phase.
  • The protocol design required strict masking procedures; separating a small injecting team led by the PI.
  • It was a particularly challenging start-up period due to many sites having to focus on the completion of lengthy certification activities, as well to ensure site contracts were completed and executed on time.
  • Performing a 12-month interim analysis on time was also challenging, to ensure the high global volume of patient data was clean, which occurred during a summer vacation period.

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