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

2026년 6월 26일 업데이트: Gemmy Cheung Chui Ming, Singapore National Eye Centre

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

50

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Intravitreal injection (IVT) arm
의약품: 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.
가짜 비교기: Sham arm
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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).
기간: 3 months.
Assessed by the proportion of eyes achieving achieving complete resolution of SRF on optical coherence tomography (OCT) at Month 3.
3 months.

2차 결과 측정

결과 측정
측정값 설명
기간
The proportion of eyes achieving a ≥20% reduction in central retinal thickness (CRT) from baseline at month 3 and month 6.
기간: 6 months.
6 months.
The proportion of eyes achieving complete resolution of intraretinal and/or SRF from month 1 through month 6.
기간: 6 months.
6 months.
The time to first resolution of intraretinal and/or SRF.
기간: 6 months.
6 months.
The mean change in best corrected visual acuity (BCVA) from baseline to months 3 and 6.
기간: 6 months.
6 months.
The mean change in CRT from baseline to months 3 and 6.
기간: 6 months.
6 months.
The number of intravitreal faricimab injections administered from baseline through month 6.
기간: 6 months.
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.
기간: Measurements will be obtained at baseline, Month 3, and Month 6, from the central foveal B-scan.
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.
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).
기간: 6 months.
6 months.
Exploratory Analysis of Baseline Qualitative OCT Structural Features as Predictors of Treatment Response.
기간: Baseline imaging with outcome assessed at Month 3 and at Month 6.

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.
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.
기간: Baseline imaging with outcome assessed at Month 3 and at Month 6.
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.
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.
기간: Baseline imaging with outcome assessed at Month 3 and at Month 6.
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.
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.
기간: Baseline imaging with outcome assessed at Month 3 and at Month 6.
  • 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)
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.
기간: Baseline imaging with outcome assessed at Month 3 and at Month 6.
  • 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)
Baseline imaging with outcome assessed at Month 3 and at Month 6.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Singapore National Eye Centre

협력자

Hoffmann-La Roche

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 12월 1일

기본 완료 (추정된)

2029년 8월 1일

연구 완료 (추정된)

2029년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 11일

QC 기준을 충족하는 최초 제출

2026년 6월 26일

처음 게시됨 (실제)

2026년 7월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 26일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TBC (TBC)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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