Macular degeneration
Conditions
Interventions
Treatment group:Administration of CPP- Aflibercept eyedrops
Control group:Administration of hypermellose eyedrops
Sponsors
Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female >45 years old 2. nAMD diagnosed by clinical appearance and multimodal imaging 3. Treatment naïve nAMD patient 4. BCVA at presentation 20/400
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing (lactating) women. 2. Stroke or myocardial infarction within the last 3 months prior to Screening. 3. Known hypersensitivity to anti-VEGF or fluorescein or indocyanine green 4. Presence of macular disease other than AMD: angioid streaks, macular fibrosis, presumed ocular histoplasmosis syndrome, pathologic myopia (evidence of posterior segment abnormalities consistent with pathologic myopia). 5. Tear (rip) of the retinal pigment epithelium involving the fovea at the time of recruitment or Baseline. Fibrosis or geographic atrophy involving the fovea. 6. Active ocular inflammation or infection (ocular or periocular) at the time of recruitment or Baseline. 7. Uncontrolled intraocular hypertension or glaucoma (IOP= 30 mmHg) despite treatment with anti-glaucoma medication at the time of recruitment or Baseline. 8. Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period. 9. History of intraocular surgery in the study eye including pars plana vitrectomy and intraocular hemorrhage displacement (e.g. injection of gas with or without tissue plasminogen activator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of intravitreal injections needed in the treatment group (receiving CPP-anti-VEGF eyedrops) compared to the control group (receiving Hypromellose eyedrops).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in best corrected visual acuity (BCVA);Changes in OCT and OCT-A appearance;Changes in leakage seen on fluorescein angiography (FFA);Any ocular adverse effects (AE) or serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactDr. Mårten Erik Brelén
Department of Ophthalmology and Visual Sciences, CUHK
Outcome results
None listed