Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography (DANA)

Defining Disease Activity in Neovascular Age-related Macular Degeneration With Optical Coherence Tomography Angiography - A Prospective, Imaging Study - The DANA Study

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

• Study Contact: Name: Nadine Abdelgalil; Phone Number: 4246 020 7253411; Email: nadine.abdelgalil@nhs.net
• Study Contact Backup: Name: Lauren Leitch-Devlin; Phone Number: 2036 020 7253 3411; Email: res-admin@moorfields.nhs.uk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• 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).

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 Months

Collaborators and Investigators

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Praveen J Patel, FRCOphth, MD, Moorfields Eye Hosptial NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: OCTA; Aflibercept; Neovascular age-related macular degeneration; nAMD; Treat and Extend
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: PATP1032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No