Central Serous Chorioretinopathy (CSC)Phase 2NCT07681167
Faricimab for Chronic Central Serous Chorioretinopathy: A Randomized Sham-Controlled Trial
A Phase 2 study testing Faricimab in people with Central Serous Chorioretinopathy (CSC), run by Singapore National Eye Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Central Serous Chorioretinopathy (CSC)
- What is being tested?
- Faricimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Masked, Sham-Controlled Clinical Trial of Intravitreal Faricimab for Chronic Central Serous Chorioretinopathy With or Without Secondary Macular Neovascularization: Study Protocol for a Randomised, Double-Masked 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.
Read the detailed description
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.
- Conditions
- Central Serous Chorioretinopathy (CSC)
- Being tested
- Faricimab, Sham
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaricimabDrug
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.
ShamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal injection (IVT) arm | Active comparator | Not described Receives: Drug: Faricimab |
| Sham arm | Sham comparator | Not described Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months.
The proportion of eyes achieving complete resolution of intraretinal and/or SRF from month 1 through month 6.
Measured: 6 months.
The time to first resolution of intraretinal and/or SRF.
Measured: 6 months.
The mean change in best corrected visual acuity (BCVA) from baseline to months 3 and 6.
Measured: 6 months.
The mean change in CRT from baseline to months 3 and 6.
Measured: 6 months.
The number of intravitreal faricimab injections administered from baseline through month 6.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Baseline imaging with outcome assessed at Month 3 and at Month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous Chorioretinopathy (CSC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Gemmy Cheung Chui Ming, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681167
- Sponsor's protocol ID
- TBC
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Sham-Controlled Clinical Trial of Intravitreal Faricimab for Chronic Central Serous Chorioretinopathy With or Without Secondary Macular Neovascularization: Study Protocol for a Randomised, Double-Masked Trial
- ClinicalTrials.gov ID
- NCT07681167
- Acronym / sponsor ID
- TBC
- Conditions
- Central Serous Chorioretinopathy (CSC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Hoffmann-La Roche
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal injection (IVT) arm | Active comparator | Drug: Faricimab |
| Sham arm | Sham comparator | Drug: Sham |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FaricimabIntravitreal 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 | Intravitreal injection (IVT) arm |
| ShamSham 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. | Drug | Sham arm |
Primary outcome
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).
Time frame: 3 months.
Assessed by the proportion of eyes achieving achieving complete resolution of SRF on optical coherence tomography (OCT) at Month 3.
13 secondary outcomes
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.
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.
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.
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.
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.
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.
Time frame: Baseline imaging with outcome assessed at Month 3 and at Month 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Faricimab in people with Central Serous Chorioretinopathy (CSC), run by Singapore National Eye Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gemmy Cheung Professor (+6563224500, gemmy.cheung.c.m@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.