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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03909425
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

Brief 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. Our 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.

Condition or disease
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 we 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Defining Disease Activity in Neovascular Age-related Macular Degeneration With Optical Coherence Tomography Angiography - A Prospective, Imaging Study - The DANA Study
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : August 2, 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Proportion of treated nAMD [ Time Frame: 18 Months ]
    To determine the proportion of treated nAMD eyes with features of an 'active' CNV phenotype on OCTA imaging and concurrent inactive CNV phenotype on structural OCT.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03909425

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Contact: Nicola Harris 020 7253411 ext 4246
Contact: Lauren Leitch-Devlin 020 7253 3411 ext 2036

Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
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Principal Investigator: Praveen J Patel, FRCOphth, MD Moorfields Eye Hosptial NHS Foundation Trust

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Responsible Party: Moorfields Eye Hospital NHS Foundation Trust Identifier: NCT03909425     History of Changes
Other Study ID Numbers: PATP1032
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moorfields Eye Hospital NHS Foundation Trust:
Treat and Extend
Neovascular age-related macular degeneration

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases