NCT02441816

VITAL - Individualising Therapy for Neovascular AMD With Aflibercept

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess a new treatment pattern for aflibercept. The aim is to achieve and maintain the best benefit of visual function and avoid unnecessary hospital visits. The hypothesis to be tested is whether intravitreous aflibercept given in an 8 week cycle of treatment in year 1 and a capped treat and extend treatment paradigm in year 2 can lead to improved vision and reading speed in eyes with active wet AMD over 2 years while reducing hospital visits.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept
OTHER	Extend Treatment	In year 2 of the study a treat and extend protocol will be applied, if a patient has signs of disease activity (eg macular fluid on SDOCT) they will be brought back at 8 weeks after the visit and given an intravitreous injection. They will then be reviewed 8 weeks post treatment for a further treatment with follow-up and treatment interval extended to 10 weeks if the disease is quiescent (if no macular fluid at the subsequent visit the patient could be extended to 12 weeks interval with treatment).

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-01-26
• Completion: 2018-01-26
• First posted: 2015-05-12
• Last updated: 2018-05-23

Locations

1 site across 1 country: United Kingdom