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

NCT07681167 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-02

No results posted yet for this study

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)

Interventions

DRUG

Faricimab

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.

DRUG

Sham

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.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Singapore National Eye Centre

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2029-08-31
Completion
2029-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07681167 on ClinicalTrials.gov