A Phase 2 interventional study of Faricimab and Sham in Central Serous Chorioretinopathy (CSC), sponsored by Singapore National Eye Centre. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Singapore National Eye Centre · Phase 2, Interventional, and Treatment
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.
Current understanding of central serous chorioretinopathy (CSCR) pathophysiology has evolved from a localized retinal disorder to a disease driven primarily by choroidal venous congestion, vascular hyperpermeability, and hemodynamic dysfunction. The current treatment of choice is photodynamic therapy (PDT). However, there is a global shortage of the photosensitive dye (Verteporfin) which is required for PDT. In addition, special laser and angiography equipment are required to deliver PDT, further limiting the access to this treatment.
Persistent subretinal fluid and neovascular complications represent unmet clinical challenges in the management of CSCR and pachychoroid-associated disease. Emerging evidence from genetic studies suggests that the Angiopoietin-2 (Ang-2) pathway plays a direct role in retinal pigment epithelium (RPE) dysfunction and choroidal vascular instability, along with Tie2 receptor. These mechanisms are also believed to contribute to the choroidal congestion and subretinal fluid accumulation seen in CSCR.
The dual inhibition of Vascular Endothelial Growth Factor (VEGF)-A and Ang-2 offered by faricimab provides a mechanistic rationale for evaluating its efficacy in eyes with CSCR. To-date, only small observational studies and case series have reported macular fluid reduction following intravitreal faricimab. However, these studies are limited by small sample sizes and the absence of comparator groups, hence the need for more robust clinical evidence.
Specific aim: To evaluate the efficacy and safety of intravitreal faricimab in achieving anatomical improvements compared with sham treatment in patients with retinal fluid secondary to CSCR with/ without neovascularization.
Hypothesis: Intravitreal faricimab, through its dual inhibition of VEGF-A and Ang -2, will result in superior drying effect compared with sham treatment.
84 studies on the registry are indexed under Central Serous Chorioretinopathy; 14 are open to participants now.
This study's planned enrollment of 50 is above the median of 35 across 60 interventional studies indexed under Central Serous Chorioretinopathy.
Browse Central Serous Chorioretinopathy studies →Singapore National Eye Centre is the lead sponsor of 87 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Disease duration criteria:
Exclusion Criteria:
Prior treatment in the study eye with:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Faricimab
Drug: Sham
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.
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.
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.
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.
The proportion of eyes achieving complete resolution of intraretinal and/or SRF from month 1 through month 6.
Time frame: 6 months.
The time to first resolution of intraretinal and/or SRF.
Time frame: 6 months.
The mean change in best corrected visual acuity (BCVA) from baseline to months 3 and 6.
Time frame: 6 months.
The mean change in CRT from baseline to months 3 and 6.
Time frame: 6 months.
The number of intravitreal faricimab injections administered from baseline through month 6.
Time frame: 6 months.
Changes in subfoveal choroidal thickness (SFCT) measured by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT) from baseline to months 3 and 6.
SFCT will be assessed using EDI-OCT. SFCT is defined as the vertical distance (in micrometers) between the outer border of the retinal pigment epithelium (RPE)/Bruch's membrane complex and the choroid-scleral interface at the foveal center.
Time frame: Measurements will be obtained at baseline, Month 3, and Month 6, from the central foveal B-scan.
The proportion of eyes demonstrating reduction in height or resolution of pigment epithelial detachment (PED).
Time frame: 6 months.
Exploratory Analysis of Baseline Qualitative OCT Structural Features as Predictors of Treatment Response.
Baseline qualitative OCT structural features will be evaluated as predictors of treatment response. The following features will be assessed from spectral-domain OCT images and recorded as binary variables (present/absent): * Subretinal fluid (SRF) presence * Pigment epithelial detachment (PED) presence * Ellipsoid zone (EZ) disruption * Presence of hyperreflective foci All features will be graded using standardized criteria by masked graders.
Time frame: Baseline imaging with outcome assessed at Month 3 and at Month 6.
Exploratory Analysis of Baseline Choroidal Vascularity Index (CVI) as a Predictor of Treatment Response.
CVI, defined as the ratio of luminal to total choroidal area, will be measured on swept-source OCT (DREAM OCT, Intalight) using the device's built-in analysis tool. Values will be recorded as a proportion and reviewed by masked graders.
Time frame: Baseline imaging with outcome assessed at Month 3 and at Month 6.
Exploratory Analysis of Baseline Presence of Macular Neovascularization (MNV) on OCT Angiography as a Predictor of Treatment Response.
Baseline presence of macular neovascularization (MNV) will be assessed on OCT angiography (OCT-A) images and recorded as a binary variable (present/absent). Its association with treatment response will be evaluated.
Time frame: Baseline imaging with outcome assessed at Month 3 and at Month 6.
The correlation between baseline MNV lesion area measured on OCT angiography and treatment response will be evaluated.
* MNV lesion area: measured using the device's built-in OCT-A analysis software and recorded in square millimeters (mm²) * Treatment response: defined as complete resolution of subretinal fluid (SRF) on OCT at Month 3, recorded as a binary variable (yes/no)
Time frame: Baseline imaging with outcome assessed at Month 3 and at Month 6.
The correlation between baseline vessel density measured on OCT angiography and treatment response will be evaluated.
* Baseline vessel density will be measured on OCT angiography using the device's built-in analysis software and recorded as a percentage (%) * Treatment response: defined as complete resolution of subretinal fluid (SRF) on OCT at Month 3, recorded as a binary variable (yes/no)
Time frame: Baseline imaging with outcome assessed at Month 3 and at Month 6.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Aug 2029, 32 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Faricimab
Central Serous Chorioretinopathy →
Singapore National Eye Centre