Clinical Trials List
Protocol NumberGR40844
NCT Number(ClinicalTrials.gov Identfier)NCT03823300
Completed
2019-03-01 - 2023-12-31
Phase III
Terminated4
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)
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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
Co-Principal Investigator
- 林泰祺 Division of Ophthalmology
- 黃怡銘 Division of Ophthalmology
- De-Kuang Hwang Division of Ophthalmology
- An-Fei Li Division of Ophthalmology
- 周昱百 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yih-Shiou Hwang Division of Ophthalmology
- 周宏達 Division of Ophthalmology
- 陳冠任 Division of Ophthalmology
- 陳墩祿 Division of Ophthalmology
- 劉珍吟 Division of Ophthalmology
- Wei-Chi WU Division of Ophthalmology
- 陳彥伯 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 葉伯廷 Division of Ophthalmology
- Ta-Ching Chen Division of Ophthalmology
- TSO-TING LAI Division of Ophthalmology
- CHUNG-MAY YANG Division of Ophthalmology
- 謝易庭 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
nAMD
Objectives
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
Test Drug
Faricimab (RO6867461)
Eylea
Eylea
Active Ingredient
Aflibercept
Dosage Form
IVT
IVT
IVT
Dosage
6 mg/ 0.05 ml
2 mg/ 0.05 ml
2 mg/ 0.05 ml
Endpoints
Primary Outcome Measures :
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 [ Time Frame: From Baseline through Week 48 ]
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 [ Time Frame: From Baseline through Week 48 ]
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Inclution Criteria
Inclusion Criteria:
Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
Ability to comply with the study protocol, in the investigator's judgment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Other protocol-specified inclusion criteria may apply
Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
Ability to comply with the study protocol, in the investigator's judgment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Other protocol-specified inclusion criteria may apply
Exclusion Criteria
Exclusion Criteria:
Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
Pregnancy or breastfeeding, or intention to become pregnant during the study
CNV due to causes other than AMD in the study eye
Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
Uncontrolled glaucoma in the study eye
Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
Prior IVT administration of faricimab in either eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active ocular inflammation or suspected or active ocular or periocular infection in either eye
Other protocol-specified exclusion criteria may apply
Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
Pregnancy or breastfeeding, or intention to become pregnant during the study
CNV due to causes other than AMD in the study eye
Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
Uncontrolled glaucoma in the study eye
Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
Prior IVT administration of faricimab in either eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active ocular inflammation or suspected or active ocular or periocular infection in either eye
Other protocol-specified exclusion criteria may apply
The Estimated Number of Participants
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Taiwan
28 participants
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Global
640 participants
