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Clinical Trials List

Protocol NumberKSMP001
NCT Number(ClinicalTrials.gov Identfier)NCT06996080
Active

2025-11-01 - 2028-12-31

Phase III

Not yet recruiting1

Recruiting4

ICD-10H35.81

Retinal edema

ICD-9362.83

Retinal edema

A Multicenter Platform Study on the Safety, Tolerability, Bioactivity, and Pharmacokinetics of Intravitreal Therapies in Retinal Vascular and Inflammatory Diseases

  • Trial Applicant

    ComboTrial Consultancy Ltd .

  • Sponsor

    ComboTrial Consultancy Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/14

Investigators and Locations

Principal Investigator 姜威宇 Division of Ophthalmology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

Principal Investigator De-Kuang Hwang Division of Ophthalmology
Taipei Veterans General Hospital

Co-Principal Investigator

Principal Investigator 彭繼賢 Division of Ophthalmology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 詹維鈞 Division of Ophthalmology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yih-Shiou Hwang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Macular Edema Secondary to Inflammation

Objectives

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)

Test Drug

KSI-101

Active Ingredient

Tabirafusp alfa

Dosage Form

Injection

Dosage

33 mg/0.33 mL

Endpoints

Mean change in BCVA Mean change in BCVA from Day 1 to the average of Week 20 and Week 24. Week 24

Inclution Criteria

Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥320 and <400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between ~20/25 and 20/320 Snellen equivalent) in the Study Eye.
Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye.
Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.

Exclusion Criteria

ME in the Study Eye secondary to diabetes, RVO, or wAMD.
Active or suspected ocular or periocular infection in either eye.
Any history of or active occlusive retinal vasculitis in either eye.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    900 participants

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