VITAL - Individualising Therapy for Neovascular AMD With Aflibercept

Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Study ID
NCT02441816
Phase
PHASE4
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
  • Extend Treatment — OTHER
    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).

Study Details

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.

Key Dates

Start date
Nov 30, 2014
Status verified
May 2018
Primary completion
Jan 26, 2018
Completion
Jan 26, 2018

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Eylea Treatment
    The intravitreal dose of Eylea will be 2mg (in 0.05ml) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks in the first year of treatment before applying a treat and extend paradigm to patient visits in year 2. This is an open-label study.

Primary Outcome Measure

Primary outcome - mean change in visual acuity (Early Treatment of Diabetic Retinopathy Study letter score) [ Time Frame: 24 months ]

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