AMD Clinical Trial
— FENETREOfficial title:
Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial
Verified date | September 2021 |
Source | Moorfields Eye Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Moorfields Eye Hospital NHS Foundation Trust, 162 City Road | London |
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 |
United Kingdom,
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 |
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