NCT03893474

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
742

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

March 26, 2019

Last Update Submit

September 16, 2021

Conditions

AMD

Keywords

AMDnAMD

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • 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')

    12 months

  • 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

    12 months

  • Rate of patient non-attendance and loss to follow up in secondary and primary care

    12 months

  • +3 more secondary outcomes

Study Arms (2)

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.

Diagnostic Test: OCTDiagnostic 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.

Diagnostic Test: OCTDiagnostic Test: Visual Acuity

Interventions

OCTDIAGNOSTIC_TEST

Optical Coherence Tomography of study eye.

Control ArmStudy Arm
Visual AcuityDIAGNOSTIC_TEST

Visual acuity measured by ETDRS

Control ArmStudy Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, EC1V 2PD, United Kingdom

RECRUITING

Related Publications (1)

  • Learoyd 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.

    PMID: 33980536DERIVED

MeSH Terms

Interventions

Visual Acuity

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisOcular Physiological Phenomena

Study Officials

  • Konstantinos Balaskas

    Moorfields Eye Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

September 30, 2019

Primary Completion

May 1, 2022

Study Completion

November 1, 2022

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.

Locations

GB(1)