Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners (FENETRE)
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| ClinicalTrials.gov Identifier: NCT03893474 |
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Recruitment Status :
Recruiting
First Posted : March 28, 2019
Last Update Posted : September 17, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| AMD | Diagnostic Test: OCT Diagnostic Test: Visual Acuity | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 742 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial |
| Actual Study Start Date : | September 30, 2019 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | November 2022 |
| Arm | Intervention/treatment |
|---|---|
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Control Arm
All investigations are the same in both arms, but patients within this arm will be seen in the hospital as per standard practice.
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Diagnostic Test: OCT
Optical Coherence Tomography of study eye. Diagnostic Test: Visual Acuity Visual acuity measured by ETDRS |
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Study Arm
All investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice.
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Diagnostic Test: OCT
Optical Coherence Tomography of study eye. Diagnostic Test: Visual Acuity Visual acuity measured by ETDRS |
- The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives). [ Time Frame: 12 months ]The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).
- 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. [ Time Frame: 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.
- Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives) [ Time Frame: 12 months ]Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives)
- Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious') [ Time Frame: 12 months ]Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious')
- Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups [ Time Frame: 12 months ]Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups
- Rate of 'suspicious' lesion classification in community care [ Time Frame: 12 months ]Rate of 'suspicious' lesion classification in community care
- Rate of patient non-attendance and loss to follow up in secondary and primary care [ Time Frame: 12 months ]Rate of patient non-attendance and loss to follow up in secondary and primary care
- Use of health services and patient costs collected via eCRF and participant completed questionnaires [ Time Frame: 12 months ]Use of health services and patient costs collected via eCRF and participant completed questionnaires
- Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime [ Time Frame: 12 months ]Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime
- Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L. [ Time Frame: 12 months ]Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893474
| United Kingdom | |
| Moorfields Eye Hospital NHS Foundation Trust, 162 City Road | Recruiting |
| London, United Kingdom, EC1V 2PD | |
| Contact: Lauren Leitch-Devlin 020 7253 3411 moorfields.resadmin@nhs.net | |
| Principal Investigator: Konstantinos Balaskas | |
| Principal Investigator: | Konstantinos Balaskas | Moorfields Eye Hospital NHS Foundation Trust |
| Responsible Party: | Moorfields Eye Hospital NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT03893474 |
| Other Study ID Numbers: |
BALK1005 |
| First Posted: | March 28, 2019 Key Record Dates |
| Last Update Posted: | September 17, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | IPD will not be shared. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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AMD nAMD |
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Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |