Monitoring for neovascular AMD reactivation at home
- Conditions
- Age-related macular degeneration (AMD) and neovascular age-related macular degeneration (nAMD)Eye Diseases
- Registration Number
- ISRCTN79058224
- Lead Sponsor
- The Queen's University Belfast
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32367004/ protocol (added 05/10/2020) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38453199/ (added 08/03/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39023220/ (added 19/07/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 297
Current participant inclusion criteria as of 05/08/2019:
1. Aged =50 years old
2. At least one eye meeting ALL the inclusion criteria for a study eye
2.1. Eye first treated for active nAMD = 6 months ago
2.2. Eye first treated for active nAMD not more than 42 months ago
2.3. Eye currently being monitored for nAMD disease by the NHS
Previous participant inclusion criteria:
1. Patients =50 years old diagnosed with active nAMD (= 6 months earlier) and currently being treated with an anti-VEGF drug or monitored (i.e. with active or inactive nAMD) by the NHS
2. Within 42 months of first treatment for nAMD
Current participant exclusion criteria as of 05/08/2019:
1. Vision in the eye being monitored limited by another eye condition
2. Surgery in the study eye in the previous 6 months
3. Refractive error in the eye being monitored >-6D
4. Retinal or choroidal neovascularization in the eye being monitored not due to nAMD
5. Inability to do one or more of the proposed tests as assessed during ‘further information and training’ session
6. Unable to understand English
7. Unable to comply with proposed home testing
8. Vision is worse than Snellen score 6/60, LogMar 1.04 or 33 letters
Previous participant exclusion criteria:
1. Vision in the eye being monitored limited by another eye condition
2. Surgery in the study eye in the previous 6 months
3. Refractive error in the eye being monitored >-6D
4. Retinal or choroidal neovascularization in the eye being monitored not due to nAMD
5. Inability to do one or more of the proposed tests as assessed during ‘further information and training’ session
6. Unable to understand English
7. Unable to comply with proposed home testing
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is classification of a study eye at a visit as having active or inactive disease. For the reference classification, this is the reviewing ophthalmologist’s decision at a monitoring visit about the activity status of the eye being monitored (definitely active, definitely inactive, ambiguous). Data will also be collected on whether an injection is ordered/given, though this may not correlate perfectly with classification by lesion activity as (a) a patient may decide to refuse further injections or a patient’s health may preclude it or (b) an injection may be given when a lesion is inactive, e.g. in the context of a treat-and-extend regimen. For the index texts, alternative criteria for classification will be explored to maximise test performance. Participants will complete home monitoring tests and routine hospital follow-up for at least 12 months (from consent until the end of study).
- Secondary Outcome Measures
Name Time Method