A community-based monitoring programme for the early detection of wet age-related macular degeneration

early Detection Of neovascular age-Related mAcular Degeneration in the cOmmunity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10005321

Enrollment

130

Registered

2024-11-08

Start date

2024-06-06

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Specialty: Ophthalmology, Primary sub-specialty: Retina (including Diabetes)

Interventions

This is a randomised controlled trial assessing the differences between standard care and an OCT intervention program for monitoring early signs of neovascular age-related macular degeneration (nAMD).

Eligibility

Sex/Gender

All

Age

50 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. VA > 24 letters 2. Age > 50 years 3. OCT biomarkers: 3.1. Medium drusen with pigmentary abnormalities 3.2. Large drusen with or without pigmentary abnormalities 3.3. Subretinal drusenoid deposits (pseudo-reticular drusen) with or without pigmentary abnormalities 3.4. Geographic atrophy > 175µm, extrafoveal 3.5. Vitelliform lesions with visual acuity < 62 ETDRS letters (6/18) 3.6. Serous PED without neovascularisation

Exclusion criteria

Exclusion criteria: 1. Non-AMD macular degeneration, e.g., myopic degeneration, inherited macular dystrophy, MACTEL 2. Diabetic macular oedema 3. Macular haemorrhage of other causes, e.g., retinal vein occlusion 4. nAMD in both eyes 5. nAMD in one eye with the fellow eye under regular monitoring in secondary care 6. Intraretinal or subretinal haemorrhage 7. Inability to consent or comply with the trial visits 8. Inability to receive pupil dilation

Design outcomes

Primary

Measure	Time frame
1. Participant acceptability is measured using the Theoretical Framework of Acceptability (TFA) questionnaire at 12 months 2. Attendance, adherence and persistence is measured using attendance data between baseline and 12 months 3. Changes in visual acuity are measured using ETDRS or Snellen scores between baseline and 12 months 4. Changes in quality-of-life and well-being are measured using the following questionnaires at baseline and 12 months: MacDQoL, NEI-VFQ-25, EQ-5D-3L, PHQ9 5. Acceptability of participating sites in conducting the monitoring programme will be measured using the Theoretical Framework of Acceptability (TFA) questionnaire at 12 months	—

Measure

Time frame

1. Participant acceptability is measured using the Theoretical Framework of Acceptability (TFA) questionnaire at 12 months 2. Attendance, adherence and persistence is measured using attendance data between baseline and 12 months 3. Changes in visual acuity are measured using ETDRS or Snellen scores between baseline and 12 months 4. Changes in quality-of-life and well-being are measured using the following questionnaires at baseline and 12 months: MacDQoL, NEI-VFQ-25, EQ-5D-3L, PHQ9 5. Acceptability of participating sites in conducting the monitoring programme will be measured using the Theoretical Framework of Acceptability (TFA) questionnaire at 12 months

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

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