NCT03909425

Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Neovascular Age-related Macular Degeneration

Timeline

• Start date: 2019-09-02
• Primary completion: 2021-08-16
• Completion: 2021-08-16
• First posted: 2019-04-10
• Last updated: 2023-11-30

Locations

1 site across 1 country: United Kingdom