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

AMD Clinical Trial

— FENETRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03893474
• Other study ID #: BALK1005
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: November 2022

Study information

• Verified date: September 2021
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 742
• Est. completion date: November 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• AMD
• Macular Degeneration

Intervention

Diagnostic Test:
• OCT
Optical Coherence Tomography of study eye.
• Visual Acuity
Visual acuity measured by ETDRS

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust, 162 City Road	London

Sponsors (12)

Lead Sponsor

Collaborator

Moorfields Eye Hospital NHS Foundation Trust

Bradford Teaching Hospitals NHS Foundation Trust, Cardiff University, City, University of London, King's College London, Leeds Teaching Hospital NHS Foundation Trust, Manchester University NHS Foundation Trust, National Institute for Health Research, United Kingdom, Newcastle University, University College, London, University Hospitals Bristol and Weston NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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
Secondary	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
Secondary	Rate of 'suspicious' lesion classification in community care	Rate of 'suspicious' lesion classification in community care	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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