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A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

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ClinicalTrials.gov Identifier: NCT03823300
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Drug: Faricimab Drug: Aflibercept Drug: Sham Procedure Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Faricimab Drug: Faricimab
Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
Other Names:
  • RO6867461
  • RG7716

Drug: Sham Procedure
The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.

Active Comparator: Aflibercept Drug: Aflibercept
Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
Other Name: Eylea

Drug: Sham Procedure
The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.




Primary Outcome Measures :
  1. Average Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 48 [ Time Frame: From Baseline up to 48 weeks ]
    BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters


Secondary Outcome Measures :
  1. Change from Baseline in BCVA Over Time [ Time Frame: From Baseline up to 112 weeks ]
  2. Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  3. Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  4. Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  5. Percentage of Participants Gaining ≥0 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  6. Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  7. Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  8. Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  9. Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  10. Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time [ Time Frame: Up to 112 weeks ]
  11. Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time [ Time Frame: Up to 112 weeks ]
  12. Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time [ Time Frame: Up to 112 weeks ]
  13. Percentage of Participants on Different Treatment Intervals at Weeks 48, 60, and 112 [ Time Frame: Weeks 48, 60, and 112 ]
  14. Number of Study Drug Injections Received Through Weeks 48, 60, and 112 [ Time Frame: Weeks 48, 60, and 112 ]
  15. Average Change from Baseline in Central Subfield Thickness (CST) at Week 48 [ Time Frame: From Baseline up to 48 weeks ]
  16. Change from Baseline in CST Over Time [ Time Frame: From Baseline up to 112 weeks ]
  17. Percentage of Participants with Absence of Intraretinal Fluid Over Time [ Time Frame: Up to 112 weeks ]
  18. Percentage of Participants with Absence of Subretinal Fluid Over Time [ Time Frame: Up to 112 weeks ]
  19. Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time [ Time Frame: Up to 112 weeks ]
  20. Percentage of Participants with Absence of Intraretinal Cysts Over Time [ Time Frame: Up to 112 weeks ]
  21. Percentage of Participants with Absence of Pigment Epithelial Detachment Over Time [ Time Frame: Up to 112 weeks ]
  22. Change from Baseline in Total Area of Choroidal Neovascularization (CNV) Lesion at Weeks 48 and 112 [ Time Frame: Baseline, Weeks 48 and 112 ]
  23. Change from Baseline in Total Area of CNV Leakage at Weeks 48 and 112 [ Time Frame: Baseline, Weeks 48 and 112 ]
  24. Percentage of Participants with Ocular Adverse Events [ Time Frame: Up to 116 weeks ]
  25. Percentage of Participants with Non-Ocular Adverse Events [ Time Frame: Up to 116 weeks ]
  26. Plasma Concentration of Faricimab Over Time [ Time Frame: Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112 ]
  27. Percentage of Participants with Presence of Anti-Drug Antibodies [ Time Frame: Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823300


Contacts
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Contact: Reference Study ID Number: GR40844 www.roche.com/about_roche/roche_worldwide.htm 888-662-6782 (U.S. Only) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03823300     History of Changes
Other Study ID Numbers: GR40844
2018-004042-42 ( EudraCT Number )
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hoffmann-La Roche:
AMD
nAMD
neovascular age-related macular degeneration
choroidal neovascularization secondary to age-related macular degeneration

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases