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

Moorfields Eye Hospital NHS Foundation Trust

Status: Unknown

Conditions: AMD

Treatments: Diagnostic Test: OCT; Diagnostic Test: Visual Acuity

Study type: Interventional

Funder types: Other

Identifiers

NCT03893474

BALK1005

Details and patient eligibility

About

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

Full 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.

Enrollment: 742 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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742 participants in 2 patient groups

Control Arm

Other group

Description:

All investigations are the same in both arms, but patients within this arm will be seen in the hospital as per standard practice.

Treatment:

Diagnostic Test: Visual Acuity

Diagnostic Test: OCT

Study Arm

Other group

Description:

All investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice.

Treatment:

Diagnostic Test: Visual Acuity

Diagnostic Test: OCT