Clinical Trials List
Protocol NumberGR41984
NCT Number(ClinicalTrials.gov Identfier)NCT04740905
Completed
2020-09-01 - 2024-10-09
Phase III
Not yet recruiting4
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
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Trial Applicant
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Sponsor
Hoffmann-La Roche
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 莊智鈞 Division of Ophthalmology
- 謝明潔 Division of Ophthalmology
- San-Ni Chen Division of Ophthalmology
- PO-LIN CHEN Division of Ophthalmology
- 童筱凡醫師 Division of Ophthalmology
- 李昆憲 Division of Ophthalmology
- 胡毓真 Division of Ophthalmology
- 鄭捷尹 Division of Ophthalmology
- 張晉維醫師 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 劉珍吟 Division of Ophthalmology
- 陳冠任 Division of Ophthalmology
- 簡如伶 無
- 陳墩祿 Division of Ophthalmology
- 周宏達 Division of Ophthalmology
- Chi-Chun Lai Division of Ophthalmology
- 陳彥伯 Division of Ophthalmology
- 康祐銓 Division of Ophthalmology
- Yih-Shiou Hwang Division of Ophthalmology
- 沈惠真 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 謝易庭 Division of Ophthalmology
- 葉伯廷 Division of Ophthalmology
- CHUNG-MAY YANG Division of Ophthalmology
- Ta-Ching Chen Division of Ophthalmology
- TSO-TING LAI Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Macular Edema Secondary to Branch Retinal Vein Occlusion
Objectives
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).
Test Drug
FARICIMAB (RO6867461)
Active Ingredient
FARICIMAB (RO6867461)
Dosage Form
IVT
Dosage
6 mg/ 0.05 ml
Endpoints
Primary Outcome Measures :
Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24 [ Time Frame: Baseline and Week 24 ]
Secondary Outcome Measures :
Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 2: Change from Baseline in BCVA at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 72 [ Time Frame: Baseline and Week 72 ]
Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants on Different Treatment Intervals at Week 72 [ Time Frame: Week 72 ]
Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72 [ Time Frame: From Week 24 to Week 72 ]
Part 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [ Time Frame: From Baseline until end of study (up to 72 weeks) ]
Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [ Time Frame: From Baseline until end of study (up to 72 weeks) ]
Plasma Concentration of Faricimab Over Time [ Time Frame: Predose at Day 1, Weeks 4, 24, 28, 52, and 72 ]
Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study [ Time Frame: Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72 ]
Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24 [ Time Frame: Baseline and Week 24 ]
Secondary Outcome Measures :
Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
Part 2: Change from Baseline in BCVA at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 72 [ Time Frame: Baseline and Week 72 ]
Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
Part 2: Percentage of Participants on Different Treatment Intervals at Week 72 [ Time Frame: Week 72 ]
Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72 [ Time Frame: From Week 24 to Week 72 ]
Part 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Part 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [ Time Frame: From Baseline until end of study (up to 72 weeks) ]
Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [ Time Frame: From Baseline until end of study (up to 72 weeks) ]
Plasma Concentration of Faricimab Over Time [ Time Frame: Predose at Day 1, Weeks 4, 24, 28, 52, and 72 ]
Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study [ Time Frame: Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72 ]
Inclution Criteria
Inclusion Criteria:
Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit
Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit
Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
Exclusion Criteria
Exclusion Criteria:
Any major illness or major surgical procedure within 1 month before screening
Uncontrolled blood pressure
Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
Pregnant or breastfeeding, or intending to become pregnant during the study
Ocular Exclusion Criteria for Study Eye:
History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
Macular laser (focal/grid) in the study eye at any time prior to Day 1
Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)
Ocular Exclusion Criteria for Both Eyes:
Prior IVT administration of faricimab in either eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
Any major illness or major surgical procedure within 1 month before screening
Uncontrolled blood pressure
Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
Pregnant or breastfeeding, or intending to become pregnant during the study
Ocular Exclusion Criteria for Study Eye:
History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
Macular laser (focal/grid) in the study eye at any time prior to Day 1
Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)
Ocular Exclusion Criteria for Both Eyes:
Prior IVT administration of faricimab in either eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
The Estimated Number of Participants
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Taiwan
30 participants
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Global
520 participants
