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20/79 Anti-VEGF drugs compared with laser photocoagulation for the treatment of diabetic retinopathy

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research question

What is the clinical and cost-effectiveness of anti-VEGF drugs compared with laser photocoagulation for the treatment of diabetic retinopathy?

  1. Intervention: Intraocular anti-vascular endothelial growth factor (Anti-VEGF) drugs. 
  2. Patient group: People with diabetic retinopathy (any stage, severity and sub-type; applicants should note that the effectiveness of the interventions in diabetic macular oedema is not the focus of this review).  
  3. Comparator: Laser photocoagulation treatments and regimens (any available laser technologies).
  4. Study design: An evidence synthesis by systematic review and a cost-effectiveness analysis. The scope of the evidence synthesis should be broad and include any currently available anti-VEGF drugs and laser technologies used in the treatment of diabetic retinopathy (including those not currently in use in the UK). Network meta-analysis, including the use of individual patient data, may be considered if appropriate. Applicants should consider how combinations of laser and anti-VEGF drugs, sequenced treatment regimens, and results from studies enrolling participants with both retinopathy and macular oedema would be accounted for.    
  5. Outcomes and outputs: Visual acuity; peripheral vision; visual field changes; contrast sensitivity; intraocular pressure; disease progression; cost-effectiveness; adverse events; number of treatments; duration of treatment effects; withdrawal from repeat injections before optimum results; loss to follow-up; quality of life. Subgroup analyses may be considered if appropriate. The study should include an evidence map and identify unmet research needs.
    Where established Core Outcomes exist, they should be included amongst the list of outcomes unless there is good reason to do otherwise.

Rationale

Diabetic retinopathy is a complication of diabetes and one of the most common causes of irreversible blindness in the UK.

Currently, the standard treatment for advanced, sight-threatening diabetic retinopathy is panretinal laser photocoagulation, which can help stabilise the condition and is known to have lasting effects in most cases.

Anti-VEGF intravitreal injections are currently recommended for the treatment of diabetic maculopathy, but not for diabetic retinopathy. However, recently published international trials suggest potential benefit of anti-VEGF treatments in advanced diabetic retinopathy with or without macular involvement, and this has resulted in increased interest and usage of these treatments.

Anti-VEGF drugs are expensive. They need to be administered at regular intervals, thereby causing very high treatment burden to patients and to the NHS. Laser treatment, in contrast, is required less frequently than drug treatments, with only a proportion of people requiring more than two or three repeat-treatments per eye.

Eye clinics have experienced increasing patient numbers since anti-VEGF drugs became available for other eye conditions. The capacity of the NHS to further increase patient numbers is of concern, and some experts believe this could result in longer waiting times, potentially delaying treatments, and risking poorer vision outcomes in some patients.

Given the significant differences in costs, treatment burden to patients and the NHS, safety profiles and potential outcomes of these treatments, there is a need to establish and compare the clinical effectiveness of each modality and to determine their cost-effectiveness in the treatment of diabetic retinopathy.

To date, the use of anti-VEGF drugs in diabetic retinopathy may not be widespread in the NHS, but interest appears to be rising. The HTA programme therefore intends to fund the study outlined above in order to provide timely evidence to inform future clinical guidance and decision-making. The Programme Oversight Committee has estimated that the cost of this work will be around £200,000.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 23rd September 2020. Applications will be considered by the HTA Funding Committee at its meeting in November 2020.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in March 2021.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us

Email:   

htagb@nihr.ac.uk