A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 3/21/2019 |
Start Date: | March 11, 2019 |
End Date: | November 30, 2022 |
Contact: | Reference Study ID Number: GR40844 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6782 (U.S. Only) |
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)
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).
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).
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
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
We found this trial at
53
sites
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of Illinois at Chicago A major research university in the heart of one of...
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