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

2026年6月26日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

50

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Intravitreal injection (IVT) arm
薬：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.
偽コンパレータ：Sham arm
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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).
時間枠：3 months.
Assessed by the proportion of eyes achieving achieving complete resolution of SRF on optical coherence tomography (OCT) at Month 3.
3 months.

二次結果の測定

結果測定
メジャーの説明
時間枠
The proportion of eyes achieving a ≥20% reduction in central retinal thickness (CRT) from baseline at month 3 and month 6.
時間枠：6 months.
6 months.
The proportion of eyes achieving complete resolution of intraretinal and/or SRF from month 1 through month 6.
時間枠：6 months.
6 months.
The time to first resolution of intraretinal and/or SRF.
時間枠：6 months.
6 months.
The mean change in best corrected visual acuity (BCVA) from baseline to months 3 and 6.
時間枠：6 months.
6 months.
The mean change in CRT from baseline to months 3 and 6.
時間枠：6 months.
6 months.
The number of intravitreal faricimab injections administered from baseline through month 6.
時間枠：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.
時間枠：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).
時間枠：6 months.
6 months.
Exploratory Analysis of Baseline Qualitative OCT Structural Features as Predictors of Treatment Response.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Singapore National Eye Centre

協力者

Hoffmann-La Roche

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月1日

一次修了 (推定)

2029年8月1日

研究の完了 (推定)

2029年8月1日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月26日

最初の投稿 (実際)

2026年7月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月2日

QC基準を満たした最後の更新が送信されました

2026年6月26日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • TBC (TBC)

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いいえ

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