Clinical Trials List
2019-08-01 - 2022-03-31
Phase III
Recruiting4
ICD-10H35.30
Unspecified macular degeneration
ICD-9362.50
Macular degeneration (senile), unspecified
A 64-week, two-arm, randomized, double-masked, multi-center, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in patients with neovascular age-related macular degeneration (TALON)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳墩祿 無
- Wei-Chi WU 無
- 陳彥伯 無
- Yih-Shiou Hwang 無
- 周宏達 無
- 康祐銓 無
- 陳冠任 無
- 劉珍吟 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
BCVA using ETDRS-like charts
SD-OCT
Color Fundus Photography (CFP)
Fluorescein Angiography (FA)
National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) visionrelated quality of life instrument
Safety assessments:
Monitoring of Adverse Events (AE)
Ophthalmic examinations and imaging
Vital signs
Laboratory assessments (hematology, clinical chemistry, urinalysis)
Pregnancy testing
Other assessments:
OCT Angiography
Inclution Criteria
• Male or female patients ≥ 50 years of age at screening who are treatment
naive
• Active choroidal neovascularization (CNV) secondary to age-related macular
degeneration (AMD) that affects the central subfield, including retinal
angiomatous proliferation (RAP) with a CNV component, confirmed by
presence of active leakage from CNV seen by fluorescein angiography (FA)
(or other imaging modalities) and sequelae of CNV, e.g. pigment epithelial
detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE)
hemorrhage, blocked fluorescence, macular edema (study eye)
• Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the
central subfield, as seen by Spectral Domain Optical Coherence
Tomography (SD-OCT) (study eye)
• Best-corrected visual acuity (BCVA) score between 83 and 38 letters,
inclusive, at an initial testing distance of 4 meters, using Early Treatment
Diabetic Retinopathy Study (ETDRS) visual acuity charts (approximately
Snellen equivalent of 20/25 to 20/200) at both screening and baseline
visit (study eye)
Exclusion Criteria
could, in the opinion of the investigator, prevent response to study treatment
or may confound interpretation of study results, compromise visual acuity or
require planned medical or surgical intervention during the first 12-month
study period, structural damage of the fovea, atrophy or fibrosis at the center
of the fovea (study eye)
• Any active intraocular or periocular infection or active intraocular
inflammation, at screening or baseline (study eye)
• Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on
medication, or according to investigator’s judgment, at screening or baseline
(study eye)
• Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with
BCVA < 20/200 at screening (except when due to conditions which can lead
to improved visual acuity (VA) after surgery, e.g. cataract)
• Ocular treatments: previous treatment with any anti-vascular endothelial
growth factor (VEGF) drugs or investigational drugs, intraocular or periocular
steroids, macular laser photocoagulation, photodynamic therapy (PDT),
vitreoretinal surgery, intraocular surgery (study eye)
• Stroke or myocardial infarction during the 6-month period prior to baseline
• Systemic anti-VEGF therapy at any time.
The Estimated Number of Participants
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Taiwan
29 participants
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Global
734 participants
