Neovascular age-related macular degeneration(nAMD), polypoidal choroidal vasculopathy (PCV)
Conditions
Interventions
Real-world study – Part 1 (SDOCT images):N/A
Real-world study – Part 2 (nAMD):3 loading doses of Beovu, Eylea or Lucentis as clinically indicated every 1 month
BCVA and SDOCT exam 4-6 weeks after the third injection
Real-world study – Part 2 (PCV):3 loading doses of Beovu, Eylea or Lucentis as clinically indicated every 1 month
Control subjects for genetic study:N/A
Sponsors
Research Office, Health Bureau
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Real-world, hospital-based study involves two parts, one being a retrospective design and the other prospective. All subjects will be recruited from the Hong Kong Eye Hospital (HKEH) and Prince of Wales Hospital (PWH). All patients will be Hong Kong Chinese with a similar genetic and environmental background. For Part-1, we will utilize the SDOCT images already collected from HKEH and PWH (we have documented ~800 eligible patients from each centre). For Part-2, we will prospectively recruit 600 patients (300 nAMD and 300 PCV) and perform SDOCT and other ophthalmic examinations. SDOCT device models used by the two hospitals are the same. (1) Inclusion criteria for Part-1: nAMD/PCV (at a 1:1 ratio) eyes treated as clinically-indicated and at least 3 anti-VEGF injections given at monthly interval, with gradable SDOCT images at baseline graded by ophthalmologists or trained technicians or optometrists between 1 January 2018 and 31 December 2022. (2) Inclusion criteria for Part-2: Treatment naïve eyes with nAMD/PCV pending for anti-VEGF treatment (n=100 for each of the three anti-VEGF agents); patients who prefer to continue their follow-up at the public hospitals over CUHK Eye Centre or CUHK Medical Centre and receive injections of one of the anti-VEGF agents per clinical judgment with variable waiting time to begin treatment; willing to provide informed consent. The planned sample size will be 100x3 for nAMD and 100x3 for PCV. 2. Control subjects for genetic study: We have recruited 1,000 healthy controls subjects aged >50 years with no major eye diseases from the following studies between 1 September 2014 and 31 December 2020. Venous blood samples have been collected. (1) Placental Growth Factor: a New Biomarker for Age-related Macular Degeneration (Ref.: KC/KE-16-0017/ER-2; 2016.039). (2) Identification and characterization of common and rare gene variants for neovascular age-related macular degeneration and polypoidal choroidal vasculopathy (Ref.: KC/KE-14-0062/ER-1; 2014.211)..
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for Part-1: patient with missing clinical data, or eyes with ungradable OCT images, or patients with anterior segment abnormalities that might affect fundus imaging, e.g., dense cataract and corneal scar. 2. Exclusion criteria for Part-2: same as Part-1. 3. Exclusion criteria for Control subjects for genetic study: any maculopathies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy assessment (real-world study);Pharmacogenetic associations of the SNPs with nAMD and PCV;Deep learning models; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy assessment (real-world study);the genetic and other biomarkers identified for nAMD/PCV; | — |
Countries
China
Contacts
Public ContactProf Lijia Chen
Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
Outcome results
None listed