Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography (DANA)
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|ClinicalTrials.gov Identifier: NCT03909425|
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03909425
|Contact: Nicola Harris||020 7253411 ext firstname.lastname@example.org|
|Contact: Lauren Leitch-Devlin||020 7253 3411 ext email@example.com|
|Principal Investigator:||Praveen J Patel, FRCOphth, MD||Moorfields Eye Hosptial NHS Foundation Trust|