CClinicalTrials.gg
CompletedNCT03909425DANAUpdated Nov 30, 2023

Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography

An observational study in Neovascular Age-related Macular Degeneration, sponsored by Moorfields Eye Hospital NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Moorfields Eye Hospital NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
50 Years and older
Sex
All
01

Study summary

The purpose of this study is to be able to describe optical coherence angiography (OCTA) patterns of disease activity and quiescence in eyes that have received treatment. The target population group is patients that have neovascular age-related macular degeneration and have had treatment with aflibercept for this condition.

This is a single-site study and does not involve any masking or treatment allocation.

Read the detailed description

Treatment of this condition (neovascular age-related macular degeneration - nAMD) with aflibercept has transformed the outlook for patients with this sight-threatening disease.

In clinical practice, eye doctors commonly use a "treat and extend" approach to treatment in which the interval between aflibercept injections is gradually increased once there is nAMD disease quiescence.

It is uncertain about the ideal retinal imaging biomarkers doctors should use to define disease remission or inactivity; and therefore extend treatment intervals. Increased certainty of the ideal biomarker would also avoid stopping treatment too soon.

The scan the investigators will be performing (OCTA imaging) detects blood flow within the choroidal neovascular membrane (CNV) - the immature blood vessel network which causes nAMD. This scan is therefore a potentially powerful way of determining if the disease is active or quiescent. Disease activity on this device can be defined as a blood flow pattern which suggests an active CNV or lesion growth.

By better defining disease activity using OCTA, eye doctors would be more confident in continuing and defining a treatment plan for nAMD.

02

Conditions studied

  • Neovascular Age-related Macular Degeneration

Keywords

  • nAMD
  • Treat and Extend
  • Aflibercept
  • OCTA
  • Neovascular age-related macular degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 35 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with nAMD attending Moorfields Eye Hospital who show no signs of disease activity after treatment with anti-VEGF injections (no signs of macular fluid or macular haemorrhage).

Inclusion criteria

  • Patients over 50 years of age with a diagnosis of nAMD receiving anti-VEGF treatment with no signs of intra-or subretinal fluid on structural OCT imaging and with no macular haemorrhage after a minimum of three intravitreal injections
  • Visual acuity in the study eye of 35 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score or better (6/60 or better)
  • Ability to understand the nature/purpose of the study and to provide informed consent
  • Any ocular condition which would lead to image artefact or poor OCT image quality
  • Ability to undergo retinal imaging

Exclusion criteria

Exclusion Criteria:

  • Patients with polypoidal choroidal vasculopathy or pachychoroid
  • Patients in whom imaging of the study eye leads to ungradable OCTA images.
  • Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of participants treated nAMD

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

    Time frame: 18 Months

07

Study locations

1 site
  • Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
    London, EC1V 2PD, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03909425
Lead sponsor
Moorfields Eye Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
Apr 10, 2019
Start date
Sep 2, 2019
Primary completion
Aug 16, 2021
Completion
Aug 16, 2021
Last update
Nov 30, 2023

Study contacts

Praveen J Patel, FRCOphth, MD
principal investigator · Moorfields Eye Hosptial NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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