neovacular age-related macular degeneration (nAMD)
Conditions
Interventions
Treatment group (Group 1)::A single non-vitrectomised subretinal Faricimab (6mg/0.05ml) injection at the start of treatment, then followed retreatment by intravitreal Faricimab (6mg/0.05ml) injections
Control group (Group 2):3 loading doses of monthly intravitreal of Faricimab (6mg/0.01ml) followed retreatment by PRN basis.
Sponsors
Department of Ophthalmology and Visual Sciences, CUHK
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Male or female >60 years old. 2. nAMD diagnosed by clinical appearance and multimodal imaging (optical coherence tomography scans of the macula and fluorescein angiography). 3. BCVA at presentation 20/400.
Exclusion criteria
Exclusion criteria: 1. Stroke or myocardial infarction within the last 3 months prior to screening. 2. Known hypersensitivity to anti-VEGF or fluorescein or indocyanine green. 3. Presence of macular disease other than AMD. 4. Tear (rip) of the retinal pigment epithelium involving the fovea at the time of recruitment or baseline. Fibrosis or geographic atrophy involving the fovea. 5. Prior intravitreal injection of anti-VEGF or steroid in the study eye. 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 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. Patients who are incompetent to give consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of intravitreal injections needed in the treatment group (receiving single subretinal anti-VEGF injection) compared to the control group (receiving intravitreal injection monotherapy).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in best corrected visual acuity (BCVA) as measured by ETDRS letter score compared with baseline at week 52.;Changes from baseline in central macular thickness (CMT) at week 52 as assessed on optical coherence tomography (OCT);Changes in leakage seen on fluorescein angiography (FFA) at week 52 as compared to baseline;Change from baseline in National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25);Any ocular adverse effects (AE) or serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactDr Mårten Erik BRELÉN
Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
Outcome results
None listed