Faricimab for Chronic Central Serous Chorioretinopathy: A Randomized Sham-Controlled Trial

NCT07681167 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: TBC
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Central Serous Chorioretinopathy (CSC)

Outcome Measures

Primary Outcomes (1)

• The efficacy of 3 loading doses of IVT faricimab compared with sham treatment in achieving anatomical improvement in eyes with chronic CSCR with presence of foveal sub-retinal fluid (SRF), with or without secondary macular neoascularization (MNV).

  Assessed by the proportion of eyes achieving achieving complete resolution of SRF on optical coherence tomography (OCT) at Month 3.

  3 months.

Secondary Outcomes (13)

• The proportion of eyes achieving a ≥20% reduction in central retinal thickness (CRT) from baseline at month 3 and month 6.

  6 months.

• The proportion of eyes achieving complete resolution of intraretinal and/or SRF from month 1 through month 6.

  6 months.

• The time to first resolution of intraretinal and/or SRF.

  6 months.

• The mean change in best corrected visual acuity (BCVA) from baseline to months 3 and 6.

  6 months.

• The mean change in CRT from baseline to months 3 and 6.

  6 months.

Study Arms (2)

Intravitreal injection (IVT) arm

ACTIVE COMPARATOR

Drug: Faricimab

Sham arm

SHAM COMPARATOR

Drug: Sham

Interventions

Faricimab DRUG

Intravitreal faricimab 6 mg at baseline, month 1, and month 2, followed by protocol-defined Pro Re Nata (PRN) dosing at monthly visits through Month 6.

Intravitreal injection (IVT) arm

Sham DRUG

Sham injections at baseline, month 1, and month 2. After assessment of the primary endpoint at Month 3, participants randomized to the sham arm who demonstrate persistent intraretinal and/or subretinal fluid will switch to intravitreal faricimab treatment by protocol-defined PRN dosing at monthly visits through Month 6.

Sham arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Hoffmann-La Roche: collaborator

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

faricimab; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Central Study Contacts

Gemmy Cheung Professor

CONTACT

+6563224500; gemmy.cheung.c.m@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share