Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD

NCT03386474 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CRTH258A2301E1
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 65

Brief Summary

The purpose of this extension study was to assess the safety and efficacy of the new formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The medical condition treated in the core and extension trials was neo-vascular age-related macular degeneration (nAMD).

Conditions

Neovascular Age-related Macular Degeneration

Keywords

double-masked, extension study; neovascular age-related macular degeneration; intravitreal injection; brolucizumab; aflibercept

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events

  Number of participants with ocular and non-ocular treatment emergent events with the new formulation brolucizumab 6 mg in this extension trial up to week 24 vs. the corresponding last 6 months of brolucizumab treatment in the Core trial \>= 2%. Safety assessment of the new formulation brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding Core safety data. Missing brolucizumab data were imputed using last observation carried forward (LOCF).

  Up to Week 24

Secondary Outcomes (5)

• Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit

  Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Change in BCVA From Extension Baseline at Each Post-baseline Visit

  Extension baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Patients With Positive q12w Treatment Status at Week 20

  Week 20

• Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit

  Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status for Brolucuzumab 6 mg in Extension

  Extension Baseline, Week 8, Week 16, Week 24

Study Arms (2)

Brolucizumab

EXPERIMENTAL

Brolucizumab 6 mg solution for IVT injection, single injection at Day 1 (baseline), Week 8, and Week 16 or Week 20

Drug: Brolucizumab 6 mg

Aflibercept

OTHER

Aflibercept 2 mg solution for IVT injection, single injection at Day 1 (baseline), Week 8 and Week 16 to maintain the masking of the extension trial only.

Drug: Aflibercept 2 mg

Interventions

Brolucizumab 6 mg DRUG

Administered as opthalmic solution for an intravitreal injection to the study eye

Also known as: RTH258

Brolucizumab

Aflibercept 2 mg DRUG

Administered as an opthalmic solution for intravitreal injection to the study eye

Also known as: EYELEA

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written informed consent
• Completed the core study, CRTH258A2301, also known as CRTH258-C002 as defined by assessments at Visit 26/Week 96 within ≤12 weeks of the baseline.

You may not qualify if:

• Patient discontinued the treatment or the core study prematurely at any time
• Patient received standard of care treatment for nAMD after completion of the core study
• Pregnant or nursing women and women of child-bearing potential
• Stroke or MI (myocardial infarction) within 3 months of the baseline extension visit

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (65)

Novartis Investigative Site

Peoria, Arizona, 85381, United States

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Novartis Investigative Site

Phoenix, Arizona, 85014, United States

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Novartis Investigative Site

Arcadia, California, 91006, United States

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Novartis Investigative Site

Huntington Beach, California, 92647, United States

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Novartis Investigative Site

La Jolla, California, 92093, United States

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Novartis Investigative Site

Loma Linda, California, 92354, United States

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Novartis Investigative Site

Mountain View, California, 94040, United States

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Novartis Investigative Site

Oakland, California, 94609, United States

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Novartis Investigative Site

Redlands, California, 92374, United States

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Novartis Investigative Site

Sacramento, California, 95841, United States

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Novartis Investigative Site

Colorado Springs, Colorado, 80909, United States

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Novartis Investigative Site

Golden, Colorado, 80401, United States

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Novartis Investigative Site

Bridgeport, Connecticut, 06606, United States

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Novartis Investigative Site

New London, Connecticut, 06320, United States

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Novartis Investigative Site

Altamonte Springs, Florida, 32701, United States

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Novartis Investigative Site

Deerfield Beach, Florida, 33064, United States

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Novartis Investigative Site

Fort Myers, Florida, 33912-7125, United States

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Novartis Investigative Site

Ocala, Florida, 34474, United States

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Novartis Investigative Site

Palm Beach Gardens, Florida, 33410, United States

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Novartis Investigative Site

Pensacola, Florida, 32503, United States

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Novartis Investigative Site

Sarasota, Florida, 34239, United States

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Novartis Investigative Site

Tallahassee, Florida, 32308, United States

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Novartis Investigative Site

Vero Beach, Florida, 32960, United States

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Novartis Investigative Site

Winter Haven, Florida, 33880, United States

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Novartis Investigative Site

Boise, Idaho, 83713, United States

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Novartis Investigative Site

Bloomington, Illinois, 61704, United States

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Novartis Investigative Site

Indianapolis, Indiana, 46280, United States

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Novartis Investigative Site

Leawood, Kansas, 66211, United States

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Novartis Investigative Site

Shawnee Mission, Kansas, 66204, United States

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Novartis Investigative Site

Portland, Maine, 04102, United States

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Novartis Investigative Site

Baltimore, Maryland, 21237-4350, United States

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Novartis Investigative Site

Waldorf, Maryland, 20602, United States

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Novartis Investigative Site

Las Vegas, Nevada, 89144, United States

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Novartis Investigative Site

Reno, Nevada, 89502, United States

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Novartis Investigative Site

Toms River, New Jersey, 08755, United States

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Novartis Investigative Site

Albuquerque, New Mexico, 87102, United States

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Novartis Investigative Site

Rochester, New York, 14620, United States

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Novartis Investigative Site

Rochester, New York, 14642, United States

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Novartis Investigative Site

Shirley, New York, 11967, United States

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Novartis Investigative Site

Syracuse, New York, 13224, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28210, United States

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Novartis Investigative Site

Southern Pines, North Carolina, 28387, United States

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Novartis Investigative Site

Cleveland, Ohio, 44122, United States

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Novartis Investigative Site

Cleveland, Ohio, 44195, United States

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Novartis Investigative Site

Dublin, Ohio, 43016, United States

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Novartis Investigative Site

Fairfield, Ohio, 45014, United States

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Novartis Investigative Site

Camp Hill, Pennsylvania, 17011, United States

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Novartis Investigative Site

Nashville, Tennessee, 37203, United States

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Novartis Investigative Site

Abilene, Texas, 79606, United States

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Novartis Investigative Site

Austin, Texas, 78731, United States

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Novartis Investigative Site

Fort Worth, Texas, 76104, United States

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Novartis Investigative Site

Houston, Texas, 77025, United States

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Novartis Investigative Site

Houston, Texas, 77030, United States

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Novartis Investigative Site

Plano, Texas, 75093, United States

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Novartis Investigative Site

San Antonio, Texas, 78215, United States

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Novartis Investigative Site

San Antonio, Texas, 78240, United States

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Novartis Investigative Site

Richmond, Virginia, 23235, United States

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Novartis Investigative Site

Warrenton, Virginia, 20186, United States

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Novartis Investigative Site

Silverdale, Washington, 98383, United States

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Novartis Investigative Site

Spokane, Washington, 99204, United States

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Novartis Investigative Site

University Place, Washington, 98467, United States

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Novartis Investigative Site

Morgantown, West Virginia, 26506, United States

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Novartis Investigative Site

Milwaukee, Wisconsin, 53226, United States

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Novartis Investigative Site

Arecibo, 00612, Puerto Rico

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Novartis Investigative Site

San Juan, 00907, Puerto Rico

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicatrials.com

MeSH Terms

Interventions

brolucizumab; aflibercept

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 29, 2017
• Study Start: January 15, 2018
• Primary Completion: September 6, 2018
• Study Completion: September 6, 2018
• Last Updated: January 5, 2021
• Results First Posted: April 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (63); PR (2)