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

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ClinicalTrials.gov Identifier: NCT03386474
Recruitment Status : Completed
First Posted : December 29, 2017
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to collect data on safety and efficacy of the brolucizumab 6 mg drug product intended for commercialization in patients with neovascular age-related macular degeneration (nAMD) and to support comparability to the 6 mg drug product used in Phase III.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: Brolucizumab 6 mg Drug: Aflibercept 2 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week, Double-masked, Multicenter, Two-arm Extension Study to Collect Safety and Efficacy Data on Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2301 Study
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : September 6, 2018
Actual Study Completion Date : September 6, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept

Arm Intervention/treatment
Experimental: Brolucizumab
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
Administered as an intravitreal injection to the study eye

Active Comparator: Aflibercept
Aflibercept 2 mg solution for IVT injection, single injection at Day 1 (baseline), Week 8 and Week 16
Drug: Aflibercept 2 mg
Administered as an intravitreal injection to the study eye




Primary Outcome Measures :
  1. Number of Treatment-Emergent Adverse Events [ Time Frame: Up to Week 24 ]
  2. Mean Loss in BCVA of 15 letters or more from Baseline at each post-baseline visit [ Time Frame: Baseline, up to Week 24 ]
    Measurement of visual acuity with spectacles or other visual corrective devices will be conducted in each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  3. Mean Change in BCVA from Baseline at each post-baseline visit [ Time Frame: Baseline, up to Week 24 ]
    Measurement of visual acuity with spectacles or other visual corrective devices will be conducted in each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  4. Percentage of patients with positive q12 treatment status at Week 20 [ Time Frame: Week 20 ]
    Positive treatment status will be defined as intravitreal (IVT) injections per planned dosing regimen (every 12 weeks (q12)).

  5. Mean Change in Central Sub-Field Thickness (CSFT) from Baseline at each post-baseline visit [ Time Frame: Baseline, up to Week 24 ]
    Measurement of the thickness of the retina will be conducted using Optical Coherence Tomography (OCT) and recorded in micrometers.

  6. Percentage of subjects with positive Anti-drug Antibody (ADA) status (test) [ Time Frame: Up to Week 24 ]
    Positive ADA status is defined as induced ADA status with ADA negative at predose and with a post-dose titer value increase of 2 or more dilutions at any time point or boosted ADA status with ADA positive at predose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point.



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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:

  • Sign written informed consent
  • Completed the core study, CRTH258A2301

Exclusion Criteria:

  • 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
  • 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): NCT03386474


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Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03386474     History of Changes
Other Study ID Numbers: CRTH258A2301E1
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
double-masked, extension study
neovascular age-related macular degeneration
intravitreal injection
brolucizumab
aflibercept

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