NCT02812030

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

June 22, 2016

Last Update Submit

May 2, 2017

Conditions

Diabetic Retinopathy

Keywords

Observational StudyafliberceptDiabetic RetinopathyVisual Acuity

Outcome Measures

Primary Outcomes (1)

  • Change in Best-Corrected Visual Acuity (BCVA)

    Best-corrected visual acuity using a standardised measure involving number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters.

    Baseline - 12 months

Secondary Outcomes (3)

  • Change in central retinal thickness

    Baseline - 12 months

  • Ocular adverse events

    12 months

  • Non-ocular adverse events

    12 months

Study Arms (1)

aflibercept in real world

Patients receiving aflibercept for diabetic macular oedema at Bristol Eye Hospital or Gloucestershire Hospitals NHS Foundation Trust

Other: National Eye Institute Visual Functioning Questionnaire

Interventions

National Eye Institute Visual Functioning QuestionnaireOTHER

Routine treatment plus visual functioning questionnaires

Also known as: NEIVFQ-25
aflibercept in real world

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults receiving their first ever treatment with aflibercept for diabetic macular oedema

You may qualify if:

  • Aged 18+ years
  • Eligible for NHS treatment under the auspices of Bristol Eye Hospital (3 outreach locations) or Gloucestershire NHS Foundation trust.
  • Diagnosis of centre-involving diabetic macular oedema
  • Receiving a first ever treatment of aflibercept in a new eye

You may not qualify if:

  • Any previous anti-vascular endothelial growth factor (anti-VEGF) treatment in the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Diabetic Retinopathy Clinical Research Network; Wells JA, Glassman AR, Ayala AR, Jampol LM, Aiello LP, Antoszyk AN, Arnold-Bush B, Baker CW, Bressler NM, Browning DJ, Elman MJ, Ferris FL, Friedman SM, Melia M, Pieramici DJ, Sun JK, Beck RW. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015 Mar 26;372(13):1193-203. doi: 10.1056/NEJMoa1414264. Epub 2015 Feb 18.

    PMID: 25692915BACKGROUND

  • Do DV, Nguyen QD, Boyer D, Schmidt-Erfurth U, Brown DM, Vitti R, Berliner AJ, Gao B, Zeitz O, Ruckert R, Schmelter T, Sandbrink R, Heier JS; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65. doi: 10.1016/j.ophtha.2012.02.010. Epub 2012 Apr 24.

    PMID: 22537617BACKGROUND

  • Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, Midena E, Kaiser PK, Terasaki H, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Brown DM. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014 Nov;121(11):2247-54. doi: 10.1016/j.ophtha.2014.05.006. Epub 2014 Jul 8.

    PMID: 25012934BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Clare Bailey, MA, BM, BCh(Oxon), MRCP

    University Hospitals Bristol and Weston NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Research Associate

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 23, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share