Neovascular age-related macular degeneration Eye Diseases Neovascular age-related macular degeneration
Conditions
Interventions
Participants will be randomly allocated into either the study or control arm. Randomisation will be performed by site staff using the web based randomisation tool Sealed Envelope (http://www.sealedenv
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Receiving treatment in nAMD injection clinics 2. Reached agreed definition of disease quiescence 3. Provided informed consent 4. Aged 55 years or older 5. Ability to perform study-specific procedures
Exclusion criteria
Exclusion criteria: 1. Significant media opacities (cataracts, vitreous opacities) that do not allow good quality fundus imaging 2. Diabetic retinopathy of severity worse than mild non-proliferative stage and with any degree of diabetic maculopathy 3. History of other causes of choroidal neovascularisation (myopic, angoid streaks, inflammatory, retinal dystrophies, secondary to central serous chorioretinopathy, idiopathic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives), assessed by comparison of activity assessments made by a review of clinical vignettes and ocular imaging against a reference standard provided by an expert Reading Centre. This will be assessed monthly for 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are assessed monthly for 12 months: 1. Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives) 2. Rate of over-referral (i.e. Reference Standard is quiescent but classification is ‘reactivated’ or ‘suspicious’) 3. Mean change in visual acuity (measured with habitual correction and pinhole) for patients in the intervention and control groups 4. Rate of ‘suspicious’ lesion classification in community care 5. Rate of patient non-attendance and loss to follow up in secondary and primary care The following are assessed at the baseline, after 12 months and after 18 months: 6. Use of health services and patient costs collected via an electronic case report form (eCRF) and participant completed questionnaires 7. Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime 8. Modelled estimates of visual impairment and quality-adjusted life years (QALYs) based on responses to the EQ-5D-5L | — |
Countries
England, United Kingdom
Contacts
Public ContactMoorfields Research Admin
Outcome results
None listed