An observational study following patients newly diagnosed with neovascular or 'wet' Age-related Macular Degeneration (AMD) looking at the changes within the eye both before and after treatment with anti-VEGF injection therapy

Not Applicable

Completed

• Conditions: eovascular age-related macular degeneration; Eye Diseases

• Registration Number: ISRCTN76889861
• Lead Sponsor: York Teaching Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-10
• Study Completion: 2022-02-07
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 431

Inclusion Criteria

1. The patient must have been enrolled into EDNA
2. Individuals aged 50 and over with newly diagnosed nvAMD with one eye affected and one eye unaffected who are about to commence or have recently commence anti-VEGF therapy in the affected eye
3. Exit from EDNA must be less than or equal to 12 months prior to enrolment into FASBAT
4. The patient must be willing to enter FASBAT and able to provide data and attend assessment clinics for a further 2 years following the exit of EDNA

Exclusion Criteria

1. nvAMD in study eye detected at baseline for the EDNA study
2. Presenting worse than 68 letters at baseline in the EDNA study
3. Retinal or media pathology in either eye that will prevent sufficient quality of imaging (in the view of the investigator)
4. Not undergoing regular monitoring in standard of care
5. FFA contraindicated

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence of fibrosis and sub retinal highly reflective material (SHRM) over 12 months post-conversion in the initially dry eye<br>2. Presence of fibrosis and SHRM over 12 months post-conversion in the initially nAMD eye<br>3. Rate of change of atrophy from baseline to conversion initially dry eye (based on colour photography)<br>4. Rate of change of atrophy (total and area distinct from CNV) from baseline to conversion in the initially nAMD eye (based on colour photography)<br><br>In both primary and secondary outcomes changes in disease activity are acquired using the following: colour fundus photography, autofluorescence, fluorescein, ICG and OCT angiography and SD OCT which are all acquired as part of routine clinical practice. Data and imaging is collected at baseline, 18 months post baseline, 36 months post baseline/conversion, 12 months post conversion and 24 months post conversion