Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

NCT04079231 | Withdrawn Phase 3

• 1 other identifier: CRTH258BDE01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

Conditions

Diabetic Macula Edema

Keywords

Diabetic Macula Edema; Intravitreal injection; brolucizumab; aflibercept; double-masked

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with a gain in Best Corrected Visual Acurity (BCVA) of ≥15 ETDRS letters at week 48

  BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts

  Week 48

• Mean change in BCVA from baseline to Week 48

  BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts

  Baseline, Week 48

Secondary Outcomes (19)

• Change from baseline in BCVA averaged over a period Week 36 to Week 48

  Week 36, Week 48

• Proportion of patients with a gain in BCVA of ≥10 ETDRS letters from baseline to Week 48

  Baseline, Week 48

• Proportion of patients with a loss in BCVA of ≥15 ETDRS letters from baseline to Week 48

  Baseline, Week 48

• Proportion of patients with a loss in BCVA of ≥10 ETDRS letters from baseline to Week 48

  Baseline, Week 48

• Proportion of patients maintained at q12w up to Week 48

  Baseline, Week 48

Study Arms (2)

Brolucizumab 6 mg

EXPERIMENTAL

Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule

Drug: Brolucizumab

Aflibercept 2 mg

ACTIVE COMPARATOR

Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks

Drug: Aflibercept

Interventions

Brolucizumab DRUG

Intravitreal Injection

Also known as: RTH258, ESBA1008

Brolucizumab 6 mg

Aflibercept DRUG

Intravitreal injection

Also known as: Eylea

Aflibercept 2 mg

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at Screening
• BCVA score between 23 and 65 letters, inclusive, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/50 to 20/320), at screening and baseline
• DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of ≥ 320 µm on SD-OCT

You may not qualify if:

• High risk or advanced proliferative diabetic retinopathy in the study eye as per reading Center
• Active intraocular or periocular infection or active intraocular inflammation in the study eye
• Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg)
• Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye in the last 3 months prior randomization
• Stroke or myocardial infarction during the 6-month period prior to baseline

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

brolucizumab; aflibercept

Study Design

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

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: September 6, 2019
• Study Start: February 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: March 4, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share