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Aflibercept for Retinopathy in the Real World (ARRoW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812030
Recruitment Status : Withdrawn (Superceded by a larger trial by the pharmaceutical company)
First Posted : June 23, 2016
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
University Hospitals Bristol NHS Foundation Trust
Gloucestershire Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Timothy Jones, University of Bristol

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.


Condition or disease Intervention/treatment
Diabetic Retinopathy Other: National Eye Institute Visual Functioning Questionnaire

Detailed Description:

Participants will receive treatment as usual for diabetic macular oedema at Bristol Eye Hospital (University Hospitals Bristol NHS Foundation Trust) and Gloucestershire Hospitals NHS Foundation Trust. This entails injection of aflibercept into the eye, initially with four monthly doses, then as required with regular monthly assessments. Additionally, patients will be invited to complete standardised visual functioning questionnaires at baseline and roughly 6 and 12 months. Patients will be followed up for one year for this study, but treatment will continue as necessary beyond the end of the study.

The primary outcome of Best-Corrected Visual Acuity (BCVA) will be assessed at one year and compared to the treatment arm of two recent phase 3 RCTs (VISTA and VIVID). Additional secondary outcomes of retinal thickness, visual functioning, and adverse events will also be collected.

Real world data will be collected from Bristol Eye Hospital and Gloucestershire Hospitals NHS Foundation Trust. Bristol Eye Hospital, as part of the RENOIR HIT, has set up a hub and spoke outreach model to treat patients with diabetic macular oedema, and this service has been running since September 2013. Treatment is performed at one of three outreach sites: South Bristol Community hospital, St Georges medical practice in Worle, and a mobile macular unit currently based at Cribbs Causeway. There are about three to five new patients per month commencing treatment with aflibercept in the Bristol area. In Gloucestershire, treatments are performed at Cheltenham General Hospital, and Gloucester Royal Hospital; we expect an additional two to three new patients per month from these sites.

All patients attending for routine treatment will be invited to take part in the study. In order to detect a clinically significant difference of 5 letters using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, between the real world and the clinical trials, sample size calculations suggest we will need at least 30 new patients to compare to the treatment arm of the clinical trials.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aflibercept for Retinopathy in the Real World (ARRoW) Study: Evaluation of Anti-VEGF Treatment for Diabetic Macular Oedema
Study Start Date : September 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Routine treatment plus visual functioning questionnaires
Other Name: NEIVFQ-25




Primary Outcome Measures :
  1. Change in Best-Corrected Visual Acuity (BCVA) [ Time Frame: Baseline - 12 months ]
    Best-corrected visual acuity using a standardised measure involving number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters.


Secondary Outcome Measures :
  1. Change in central retinal thickness [ Time Frame: Baseline - 12 months ]
    Central retinal thickness measured using optical coherence tomography

  2. Ocular adverse events [ Time Frame: 12 months ]
    Eye-related adverse events (e.g., endophthalmitis, uveitis, increased intraocular pressure)

  3. Non-ocular adverse events [ Time Frame: 12 months ]
    Non-eye-related adverse events (e.g., death, stroke, TIA)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults receiving their first ever treatment with aflibercept for diabetic macular oedema
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812030


Sponsors and Collaborators
Timothy Jones
University Hospitals Bristol NHS Foundation Trust
Gloucestershire Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Clare Bailey, MA, BM, BCh(Oxon), MRCP University Hospitals Bristol NHS Foundation Trust
Publications:
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Responsible Party: Timothy Jones, Senior Research Associate, University of Bristol
ClinicalTrials.gov Identifier: NCT02812030    
Other Study ID Numbers: P201
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Timothy Jones, University of Bristol:
Observational Study
aflibercept
Diabetic Retinopathy
Visual Acuity
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases