AMDFENETRENCT03893474
Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners
A study testing OCT and Visual Acuity in people with AMD, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AMD
- What is being tested?
- OCT and Visual Acuity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 742 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2019to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, EC1V 2PD
Lauren Leitch-Devlin, 020 7253 3411, moorfields.resadmin@nhs.net
Konstantinos Balaskas
About this study
Official title: Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial
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
Read the 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.
- Conditions
- AMD
- Being tested
- OCT, Visual Acuity
- Keywords
- AMD, nAMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDiagnostic test
Optical Coherence Tomography of study eye.
Visual AcuityDiagnostic test
Visual acuity measured by ETDRS
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Other | All investigations are the same in both arms, but patients within this arm will be seen in the hospital as per standard practice. Receives: Diagnostic Test: OCT; Diagnostic Test: Visual Acuity |
| Study Arm | Other | All investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice. Receives: Diagnostic Test: OCT; Diagnostic Test: Visual Acuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 months
Secondary outcomes (8)
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)
Measured: 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')
Measured: 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
Measured: 12 months
Rate of 'suspicious' lesion classification in community care
Rate of 'suspicious' lesion classification in community care
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start30 Sep 2019
- Primary completionMay 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 742 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Newcastle University, Cardiff University, City, University of London, King's College London, Manchester University NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, Leeds Teaching Hospital NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, University College, London
- Responsible party
- Sponsor
- Investigators
- Konstantinos Balaskas, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893474
- Sponsor's protocol ID
- BALK1005
- Acronym
- FENETRE
- Status last verified
- Sep 2021
- First submitted
- 26 Mar 2019
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Publications
Sharma A, Jaber A, Pal B, Lawrenson JG, Harper RA, Tufail A, Learoyd AE, Robinson E, Douiri A, Burman R, Kernohan A, Vougioukalou S, Read S, Csontos J, Jones A, Mahmood S, McKibbin M, Peacock JL, Gale R, Patel PJ, Keane PA, Hamilton R, Vale L, Bunce C, Balaskas K. Community Optometrist-Led Monitoring of Quiescent Neovascular Age-Related Macular Degeneration: The FENETRE Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2617984. doi: 10.1001/jamanetworkopen.2026.17984.
PubMed 42295759Vougioukalou S, Read SM, Csontos JK, Jones A, Jaber A, Sharma A, Balaskas K. Comparing community-based monitoring to hospital-based care of patients with quiescent age-related macular degeneration: a qualitative study of patient and practitioner perspectives on acceptability and access. BMJ Open. 2026 Feb 4;16(2):e101379. doi: 10.1136/bmjopen-2025-101379.
PubMed 41638748Learoyd AE, Tufail A, Bunce C, Keane PA, Kernohan A, Robinson E, Jaber A, Sadiq S, Harper R, Lawrenson J, Vale L, Waterman H, Douiri A, Balaskas K; FENETRE study group. FENETRE study: quality-assured follow-up of quiescent neovascular age-related macular degeneration by non-medical practitioners: study protocol and statistical analysis plan for a randomised controlled trial. BMJ Open. 2021 May 11;11(5):e049411. doi: 10.1136/bmjopen-2021-049411.
PubMed 33980536
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03893474
- Acronym / sponsor ID
- FENETRE / BALK1005
- Conditions
- AMD
- Keywords
- AMD, nAMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 742 participants (estimated)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Newcastle University, Cardiff University, City, University of London, King's College London, Manchester University NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, Leeds Teaching Hospital NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, University College, London
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Other | Diagnostic Test: OCT, Diagnostic Test: Visual AcuityAll investigations are the same in both arms, but patients within this arm will be seen in the hospital as per standard practice. |
| Study Arm | Other | Diagnostic Test: OCT, Diagnostic Test: Visual AcuityAll investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCTOptical Coherence Tomography of study eye. | Diagnostic test | Control Arm, Study Arm |
| Visual AcuityVisual acuity measured by ETDRS | Diagnostic test | Control Arm, Study Arm |
Primary outcome
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.
8 secondary outcomes
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
Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious')
Time frame: 12 months
Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups
Time frame: 12 months
Rate of 'suspicious' lesion classification in community care
Time frame: 12 months
Rate of patient non-attendance and loss to follow up in secondary and primary care
Time frame: 12 months
Use of health services and patient costs collected via eCRF and participant completed questionnaires
Time frame: 12 months
Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime
Time frame: 12 months
Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Derived from this study: PubMed 42295759Sharma A, Jaber A, Pal B, Lawrenson JG, Harper RA, Tufail A, Learoyd AE, Robinson E, Douiri A, Burman R, Kernohan A, Vougioukalou S, Read S, Csontos J, Jones A, Mahmood S, McKibbin M, Peacock JL, Gale R, Patel PJ, Keane PA, Hamilton R, Vale L, Bunce C, Balaskas K. Community Optometrist-Led Monitoring of Quiescent Neovascular Age-Related Macular Degeneration: The FENETRE Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2617984. doi: 10.1001/jamanetworkopen.2026.17984.
- Derived from this study: PubMed 41638748Vougioukalou S, Read SM, Csontos JK, Jones A, Jaber A, Sharma A, Balaskas K. Comparing community-based monitoring to hospital-based care of patients with quiescent age-related macular degeneration: a qualitative study of patient and practitioner perspectives on acceptability and access. BMJ Open. 2026 Feb 4;16(2):e101379. doi: 10.1136/bmjopen-2025-101379.
- Derived from this study: PubMed 33980536Learoyd AE, Tufail A, Bunce C, Keane PA, Kernohan A, Robinson E, Jaber A, Sadiq S, Harper R, Lawrenson J, Vale L, Waterman H, Douiri A, Balaskas K; FENETRE study group. FENETRE study: quality-assured follow-up of quiescent neovascular age-related macular degeneration by non-medical practitioners: study protocol and statistical analysis plan for a randomised controlled trial. BMJ Open. 2021 May 11;11(5):e049411. doi: 10.1136/bmjopen-2021-049411.
- Individual participant dataSharing planned: No. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, United Kingdom
Konstantinos Balaskas principal investigator
Moorfields Eye Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT and Visual Acuity in people with AMD, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03893474, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.