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

Study Overview
=================
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.

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

Conditions
-----------------
AMD

Intervention / Treatment
-----------------
* Diagnostic Test: OCT
* Diagnostic Test: Visual Acuity


Participation Criteria
=================
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).
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Arm<br>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<br>* Optical Coherence Tomography of study eye.<br>Diagnostic Test: Visual Acuity<br>* Visual acuity measured by ETDRS<br>|
| Other: Study Arm<br>All investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice. | Diagnostic Test: OCT<br>* Optical Coherence Tomography of study eye.<br>Diagnostic Test: Visual Acuity<br>* Visual acuity measured by ETDRS<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, nAMD