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

Observing fibrosis, macular atrophy and sub retinal highly reflective material before and after intervention with anti-VEGF treatment - an extension to the EDNA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN76889861

Enrollment

448

Registered

2017-05-10

Start date

2016-04-19

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular age-related macular degeneration Eye Diseases

Interventions

FASBAT is an observational extension to the EDNA study. As such only patients who have already been consented to EDNA will be approached and consented into FASBAT if willing. Any treatment given is as

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Incidence of fibrosis and sub retinal highly reflective material (SHRM) over 12 months post-conversion in the initially dry eye 2. Presence of fibrosis and SHRM over 12 months post-conversion in the initially nAMD eye 3. Rate of change of atrophy from baseline to conversion initially dry eye (based on colour photography) 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) 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	—

Measure

Time frame

1. Incidence of fibrosis and sub retinal highly reflective material (SHRM) over 12 months post-conversion in the initially dry eye 2. Presence of fibrosis and SHRM over 12 months post-conversion in the initially nAMD eye 3. Rate of change of atrophy from baseline to conversion initially dry eye (based on colour photography) 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) 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

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Secondary

Measure	Time frame
1. Mean VA and change from baseline to conversion in both eyes (Snellen scale) 2. Mean VA and change from conversion to 12 and 24 months post conversion with 15 letters gained/lost in both eyes (Snellen scale) 3. The quantity of SHRM at baseline in the initially treated eye and at conversion in the initially dry eye (correlation) 4. The change in the quantity of SHRM from baseline in the initially nAMD eye and from conversion in the initially dry eye over the study period (correlation) 5. Rate of change of SHRM stratified with baseline quantity (small and large depending upon baseline mean area), treatment type, number of treatments, visits and regimen (to the end of the study) 6. The rate of change of SHRM in those of different angiographic subgroups, leakage, presence of haemorrhage, RPE changes, IRF, SRF, ORTs, drusen or pseudo drusen 7. The quantity of fibrosis at baseline in the initially treated eye and at conversion in the initially dry eye (correlation) 8. The change in the quantity of fibrosis from baseline in the initially nAMD eye and from conversion in the initially dry eye over the study period (correlation) 9. Rate of change of fibrosis stratified with baseline quantity (small and large depending upon baseline mean area), treatment type, number of treatments, visits and regimen (to the end of the study) 10. The rate of change of fibrosis in those of different angiographic subgroups, leakage, presence of haemorrhage, RPE changes, IRF, SRF, ORTs, drusen or pseudo drusen 11. Correlation between identification (rates) of fibrosis on Colour and OCT 12. The background rate of atrophy (total and CNV distinct) in both the initially dry and nAMD eyes 13. Rate of change of atrophy (total and area distinct from CNV) in both the dry and nAMD eyes over the course of the study (correlation) 14. Rate of change of atrophy stratified with baseline area (small and large depending upon 50% baseline mean area), hyper reflective AF categories, treatment type 15. Rate	—

Measure

Time frame

1. Mean VA and change from baseline to conversion in both eyes (Snellen scale) 2. Mean VA and change from conversion to 12 and 24 months post conversion with 15 letters gained/lost in both eyes (Snellen scale) 3. The quantity of SHRM at baseline in the initially treated eye and at conversion in the initially dry eye (correlation) 4. The change in the quantity of SHRM from baseline in the initially nAMD eye and from conversion in the initially dry eye over the study period (correlation) 5. Rate of change of SHRM stratified with baseline quantity (small and large depending upon baseline mean area), treatment type, number of treatments, visits and regimen (to the end of the study) 6. The rate of change of SHRM in those of different angiographic subgroups, leakage, presence of haemorrhage, RPE changes, IRF, SRF, ORTs, drusen or pseudo drusen 7. The quantity of fibrosis at baseline in the initially treated eye and at conversion in the initially dry eye (correlation) 8. The change in the quantity of fibrosis from baseline in the initially nAMD eye and from conversion in the initially dry eye over the study period (correlation) 9. Rate of change of fibrosis stratified with baseline quantity (small and large depending upon baseline mean area), treatment type, number of treatments, visits and regimen (to the end of the study) 10. The rate of change of fibrosis in those of different angiographic subgroups, leakage, presence of haemorrhage, RPE changes, IRF, SRF, ORTs, drusen or pseudo drusen 11. Correlation between identification (rates) of fibrosis on Colour and OCT 12. The background rate of atrophy (total and CNV distinct) in both the initially dry and nAMD eyes 13. Rate of change of atrophy (total and area distinct from CNV) in both the dry and nAMD eyes over the course of the study (correlation) 14. Rate of change of atrophy stratified with baseline area (small and large depending upon 50% baseline mean area), hyper reflective AF categories, treatment type 15. Rate

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Countries

England, Northern Ireland, United Kingdom

Contacts

Public ContactMia Porteous

mia.porteous@york.nhs.uk+44 (0)1904 725129

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026