To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

NCT04058067 | Completed Phase 3 Results DMC

• 1 other identifier: CRTH258B2304
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 24

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of Chinese patients with visual impairment due to Diabetic Macular Edema.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular edema (DME); Intravitreal injection; brolucizumab; aflibercept; macular edema; diabetic retinopathy

Outcome Measures

Primary Outcomes (2)

• Change From Baseline at Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye.

  BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.

  Baseline to Week 52

• Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 40 Through Week 52 for the Study Eye

  BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.

  Week 40 to Week 52

Secondary Outcomes (48)

• Change From Baseline by Visit up to Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye

  Baseline, Week 52

• Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 4 Through Week 52 for the Study Eye

  Week 4 to Week 52

• Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 20 Through Week 52 for the Study Eye

  Week 20 to Week 52

• Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 28 Through Week 52 for the Study Eye

  Week 28 to Week 52

• Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit

  Baseline (Week 0), Week 32, Week 36 and Week 48

Study Arms (2)

Brolucizumab 6 mg

EXPERIMENTAL

5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance

Drug: Brolucizumab

Aflibercept 2 mg

ACTIVE COMPARATOR

5 x every 4 weeks loading then every 8 weeks maintenance

Drug: Aflibercept

Interventions

Brolucizumab DRUG

5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance

Also known as: RTH258

Brolucizumab 6 mg

Aflibercept DRUG

5 x every 4 weeks loading then every 8 weeks maintenance

Also known as: Eylea

Aflibercept 2 mg

Eligibility Criteria

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

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study.
• Patients ≥18 years of age at screening
• Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) of ≤10% at screening
• Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain as stable as medically acceptable during the course of the study
• Study Eye Visual impairment due to diabetic macular edema (DME) with:
• Best-corrected visual acuity (BCVA) score between 78 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) testing charts at a starting testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening and baseline
• DME involving the center of the macula, with central subfield retinal thickness (e.g. measured from retinal pigment epithelium (RPE) to the inner limiting membrane (ILM) inclusively) of ≥320 μm on Spectral domain optical coherence tomography (SD-OCT) at screening.

You may not qualify if:

• Active Proliferative diabetic retinopathy (PDR) in the study eye as per investigator
• Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention for the duration of the study (e.g. cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization (CNV) of any cause)
• Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline
• Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema (ME), including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
• Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 mmHg on medication or according to investigator's judgment at Screening or Baseline
• Neovascularization of the iris in the study eye at screening or baseline
• Evidence of vitreomacular traction in the study eye at screening or baseline which in the opinion of the investigator, affects visual acuity
• Previous treatment with any anti-vascular growth factor (VEGF) drug or investigational drugs in the study eye

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (24)

Novartis Investigative Site

Guangzhou, Guangdong, 510060, China

Location

Novartis Investigative Site

Shantou, Guangdong, 515041, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150001, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430070, China

Location

Novartis Investigative Site

Wuxi, Jiangsu, 214002, China

Location

Novartis Investigative Site

Changchun, Jilin, 130041, China

Location

Novartis Investigative Site

Qingdao, Shandong, 2666000, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300020, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300070, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310003, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310009, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310014, China

Location

Novartis Investigative Site

Wenzhou, Zhejiang, 325027, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Beijing, 100044, China

Location

Novartis Investigative Site

Beijing, 100191, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Chongqing, 400038, China

Location

Novartis Investigative Site

Chongqing, 400042, China

Location

Novartis Investigative Site

Nanjing, 210036, China

Location

Novartis Investigative Site

Shanghai, 200031, China

Location

Novartis Investigative Site

Shanghai, 200080, China

Location

Novartis Investigative Site

Shanghai, 200092, China

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Macular Edema; Diabetic Retinopathy

Interventions

brolucizumab; aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: August 23, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: October 9, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (24)