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Aflibercept for Retinopathy in the Real World

NCT02812030 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-05-04

No results posted yet for this study

Summary

Diabetic retinopathy remains the leading cause of blindness in patients of working age in the Western World, and there is a global epidemic of diabetes. The recommended treatment for diabetic retinopathy involves injection of anti-vascular endothelial growth factor (anti-VEGF) into the eye. Based on two recent clinical trials taking place in the United States, Europe, Japan, and Australia, NICE issued guidance in July 2015 recommending that aflibercept (a particular type of anti-VEGF treatment) should be available on the NHS for patients in whom the central retina of the eye is at least 400 micrometres thick before treatment.

Real-world data can differ significantly from clinical trial data, and it is therefore very important to evaluate the impact of aflibercept in a real world setting, particularly with respect to systemic control, as patients with poor systemic control were excluded from the clinical trials. This study aims to demonstrate the efficacy of aflibercept in a real-world setting, and how this compares to the clinical trial setting.

Conditions

Interventions

OTHER

National Eye Institute Visual Functioning Questionnaire

Routine treatment plus visual functioning questionnaires

Sponsors & Collaborators

  • University Hospitals Bristol and Weston NHS Foundation Trust

    collaborator OTHER

  • Gloucestershire Hospitals NHS Foundation Trust

    collaborator OTHER

  • Timothy Jones

    lead OTHER

Principal Investigators

  • Clare Bailey, MA, BM, BCh(Oxon), MRCP · University Hospitals Bristol and Weston NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-08-31
Completion
2018-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02812030 on ClinicalTrials.gov