Clinical trial NCT03893474: Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners
Official title: Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: AMD
Keywords: AMD
nAMD
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Newcastle University
name: Cardiff University
name: City, University of London
name: King's College London
name: Manchester University NHS Foundation Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: York Teaching Hospitals NHS Foundation Trust
name: Leeds Teaching Hospital NHS Foundation Trust
name: Bradford Teaching Hospitals NHS Foundation Trust
name: University College, London
First posted: 2019-03-28
Enrollment: 742
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives)
timeFrame: 12 months
measure: Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious')
timeFrame: 12 months
measure: Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups
timeFrame: 12 months
measure: Rate of 'suspicious' lesion classification in community care
timeFrame: 12 months
measure: Rate of patient non-attendance and loss to follow up in secondary and primary care
timeFrame: 12 months
measure: Use of health services and patient costs collected via eCRF and participant completed questionnaires
timeFrame: 12 months
measure: Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime
timeFrame: 12 months
measure: Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L.
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Konstantinos Balaskas
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.