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Clinical Trials List

Protocol NumberLBS-008-CT05
NCT Number(ClinicalTrials.gov Identfier)NCT05949593
Active

2023-04-22 - 2026-10-30

Phase III

Recruiting4

ICD-10H35.30

Unspecified macular degeneration

ICD-9362.50

Macular degeneration (senile), unspecified

PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Ta-Ching Chen Division of Ophthalmology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yih-Shiou Hwang Division of Ophthalmology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-JU Lin Division of Ophthalmology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 許聖民
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Geographic Atrophy

Objectives

The purpose of this trial is to evaluate the safety and efficacy (how effective the drug) of the investigational drug Tinlarebant (or LBS-008) in the treatment of geographic atrophy (GA). This is an experimental study, meaning that the drug has not yet been approved by health authorities, including the Taiwan Food and Drug Administration (TFDA), for the treatment of GA. GA is an advanced stage of dry age-related macular degeneration (AMD). Dry AMD is a disease that affects the central area of ​​the retina (called the macula). In GA, there is extensive tissue damage, creating a central blind spot, which may affect the fovea (the center of vision, where visual acuity is highest), causing difficulty reading or recognizing faces.

Test Drug

錠劑

Active Ingredient

Tinlarebant

Dosage Form

110

Dosage

5 mg

Endpoints

• The primary efficacy endpoint of this trial was the annual rate of change in atrophic lesion growth, defined as the total area of ​​DDAF growth from baseline to month 24 (i.e., the total area of ​​atrophic lesions at month 24 [mm²] minus the baseline total area of ​​atrophic lesions [mm²], then divided by 2 years). Fundus autofluorescence (FAF) imaging assessment was also performed.

Inclution Criteria

Inclusion Criteria:

Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
Minimum BCVA is required in the study eye

Exclusion Criteria

Exclusion Criteria:

The presence of diabetic macular edema or macular disease in either eye.
Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
Uncontrolled diagnosed glaucoma in the study eye

The Estimated Number of Participants

  • Taiwan

    21 participants

  • Global

    500 participants

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