Faricimab for Chronic Central Serous Chorioretinopathy: A Randomized Sham-Controlled Trial
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Central Serous Chorioretinopathy (CSC)
In brief
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.
Key facts
- Study ID
- NCT07681167
- Run by
- Singapore National Eye Centre
- People needed
- 50
- Starts
- 2026-12-01
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2026-07-02
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Presence of intraretinal fluid and/or subretinal fluid involving the fovea, as confirmed by OCT.
- Disease duration criteria:
- CSCR without secondary MNV: persistent subretinal fluid for ≥3 months despite observation, or
- CSCR with secondary MNV: presence of exudative fluid of any duration, with neovascularization confirmed on OCTA.
- Ability and willingness to provide written informed consent.
- Women of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use a reliable form of contraception for the duration of the study.
You may not qualify if…
- 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).
- Any intraocular surgery within 3 months prior to enrollment.
- Prior treatment in the study eye with:
- Intravitreal corticosteroids (any time),
- Anti-VEGF therapy within 6 months, or
- Photodynamic therapy (any time).
- History of retinal detachment or surgery for retinal detachment, prior vitrectomy, or presence of a full-thickness macular hole.
- Evidence of vitreomacular traction that may preclude resolution of macular edema.
- Extensive intra- or subretinal hemorrhage exceeding 4 disc areas.
- Aphakia in the study eye.
- Pregnancy or breastfeeding.
- Any medical, psychiatric, or systemic condition that, in the opinion of the investigator, would make study participation unsafe or interfere with study assessments.
Full record on ClinicalTrials.gov
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