Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners (FENETRE)

Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial

This is a prospective, randomised, multi-site clinical trial testing the non-inferiority of community optometry follow-up of participants with QnAMD over 12 months

Study Overview

• Status: Recruiting
• Conditions: AMD
• Intervention / Treatment: Diagnostic test: OCT; Diagnostic test: Visual Acuity

Detailed Description

Neovascular Age-Related Macular Degeneration (nAMD) is a common vision threatening condition affecting mainly patients over the age of 65. At some point during follow-up the disease becomes inactive in many cases and does not need more injections. The risk of a flare-up is high, however, and patients need to continue to be seen every month for a significant period of time.

Hospital-based eye clinics are struggling to cope with current and expected workload for assessing and treating patients with nAMD. Transferring care of these patients to the community closer to home would ease the workload for hospital based clinics and offer a better experience of care to patients.

This study will recruit 742 patients with nAMD who have reached this inactive phase of the disease. Half of the patients that want to take part will continue to have their follow-up appointments in the hospital eye clinics as usual. The other half, chosen by chance, will have follow-up visits every month in a community optometrist practice by trained optometrists. The research team will provide the training for community optometrists.

The study will seek to show that the community based care is no less safe than hospital-based care.

The study will also check what is the impact of this different way of offering care on the NHS budget and how the patients and practitioners perceive this. The study will involve several hospital eye clinics across the country and several community optometrist practices. Meetings will also be held with patients to discuss their priorities and needs when looking at how to set up the community based eye clinics.

During meetings with patients in preparation for this research, they felt positively about the possibility to receive care closer to home.

• Study Type: Interventional
• Enrollment (Anticipated): 742
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Recruiting
    • Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
    • Contact: Lauren Leitch-Devlin; Phone Number: 020 7253 3411; Email: moorfields.resadmin@nhs.net
    • Principal Investigator: Konstantinos Balaskas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants receiving treatment in nAMD injection clinics, who have reached the agreed definition of disease quiescence
• Informed consent
• Aged > 55 years
• Ability to perform study specific procedures

Exclusion Criteria:

• Significant media opacities (cataract, vitreous opacities) that would not allow good quality fundus imaging.
• Diabetic retinopathy of severity worse than mild non-proliferative stage and with any degree of diabetic maculopathy
• History of other causes of Choroidal Neovascularisation (myopic, angioid streaks, inflammatory, retinal dystrophies, secondary to Central Serous Chorioretinopathy, idiopathic).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Arm; All investigations are the same in both arms, but patients within this arm will be seen in the hospital as per standard practice.	Diagnostic test: OCT; Optical Coherence Tomography of study eye.; Diagnostic test: Visual Acuity; Visual acuity measured by ETDRS
Other: Study Arm; All investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice.	Diagnostic test: OCT; Optical Coherence Tomography of study eye.; Diagnostic test: Visual Acuity; Visual acuity measured by ETDRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).	The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).	12 months
Primary economic outcome: Incremental cost per quality adjusted life year (QALY) gained over the estimated patient lifetime estimated from an economic model informed by trial data.	Primary economic outcome: Incremental cost per quality adjusted life year (QALY) gained over the estimated patient lifetime estimated from an economic model informed by trial data.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives)	Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives)	12 months
Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious')	Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious')	12 months
Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups	Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups	12 months
Rate of 'suspicious' lesion classification in community care	Rate of 'suspicious' lesion classification in community care	12 months
Rate of patient non-attendance and loss to follow up in secondary and primary care	Rate of patient non-attendance and loss to follow up in secondary and primary care	12 months
Use of health services and patient costs collected via eCRF and participant completed questionnaires	Use of health services and patient costs collected via eCRF and participant completed questionnaires	12 months
Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime	Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime	12 months
Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L.	Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L	12 months

Collaborators and Investigators

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Collaborators: King's College London; Cardiff University; University College, London; Newcastle University; Manchester University NHS Foundation Trust; National Institute for Health Research, United Kingdom; University Hospitals Bristol and Weston NHS Foundation Trust; City, University of London; Bradford Teaching Hospitals NHS Foundation Trust; York Teaching Hospitals NHS Foundation Trust; Leeds Teaching Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Konstantinos Balaskas, Moorfields Eye Hospital NHS Foundation Trust

Publications and helpful links

General Publications

• Learoyd AE, Tufail A, Bunce C, Keane PA, Kernohan A, Robinson E, Jaber A, Sadiq S, Harper R, Lawrenson J, Vale L, Waterman H, Douiri A, Balaskas K; FENETRE study group. FENETRE study: quality-assured follow-up of quiescent neovascular age-related macular degeneration by non-medical practitioners: study protocol and statistical analysis plan for a randomised controlled trial. BMJ Open. 2021 May 11;11(5):e049411. doi: 10.1136/bmjopen-2021-049411.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: AMD; nAMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: BALK1005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No