Faricimab for Chronic Central Serous Chorioretinopathy: A Randomized Sham-Controlled Trial
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorSingapore National Eye Centre
About this trial
Dysregulation of the Angiopoietin-2 (Ang-2)/Tyrosine kinase with Immunoglobulin-like and EGF-like domains 2 (Tie-2) signaling pathway has been implicated in choroidal vascular instability and RPE dysfunction in Central serous chorioretinopathy (CSCR) and pachychoroid-associated neovascularization.
This study prospectively evaluates the efficacy and safety of faricimab compared to sham in CSCR with and without secondary neovascularization, using standardized anatomical and functional endpoints. The results of this trial may help define the role of dual pathway inhibition in CSCR and inform future treatment strategies for this challenging and vision threatening condition.
Eligibility criteria
Qualifiers
Age ≥21 years at the time of consent.
Best corrected visual acuity between 24 and 73 ETDRS letters (approximately Snellen equivalent 20/32 to 20/300) in the study eye.
Diagnosis of chronic CSCR, defined as the presence of persistent SRF for ≥3 months, with or without secondary MNV.
Presence of pachychoroid features, including pachyvessels on ultra-widefield imaging in at least one quadrant and SFCT ≥300 µm.
Disqualifiers
Presence of ocular inflammation or primary choroidal disorders.
Presence of polypoidal choroidal vasculopathy (PCV).
Any ocular condition that, in the opinion of the investigator, could affect intra- or subretinal fluid or significantly alter visual acuity during the study (e.g., diabetic macular edema, retinal vein occlusion, uveitis, neovascular glaucoma).
Clinically significant cataract likely to reduce visual acuity by more than three ETDRS lines (i.e., worse than approximately 20/40 if the eye were otherwise normal).
Trial design
Treatments tested in this trial
- Faricimab
- Sham
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Singapore National Eye Centre
Lead sponsor
Hoffmann-La Roche
Collaborator
Source ClinicalTrials.gov