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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Faricimab
DrugIntravitreal 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.
Sham
DrugSham 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Intravitreal injection (IVT) armActive comparator 1 intervention
Group B: Sham armSham comparator 1 intervention
Trial outcomes
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.
Time frame
3 months.Secondary outcomes
1
The proportion of eyes achieving a ≥20% reduction in central retinal thickness (CRT) from baseline at month 3 and month 6.
Time frame
6 months.2
The proportion of eyes achieving complete resolution of intraretinal and/or SRF from month 1 through month 6.
Time frame
6 months.3
The time to first resolution of intraretinal and/or SRF.
Time frame
6 months.4
The mean change in best corrected visual acuity (BCVA) from baseline to months 3 and 6.
Time frame
6 months.Locations
Sponsors and contacts
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Singapore National Eye Centre
Lead sponsor
Hoffmann-La Roche
Collaborator
Source ClinicalTrials.gov
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