Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema

NCT06498050 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: CRTH258BCN03T
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of brolucizumab 6 mg in Chinese patients with persistent diabetic macular edema (DME). It will also learn about the safety of brolucizumab 6 mg. The main questions it aims to answer are: Does brolucizumab 6 mg reduce central subfield thickness (CST) and improve best-corrected visual acuity (BCVA) of participants? What medical problems do participants have after receiving intravitreal injections of brolucizumab 6 mg? Researchers will compare baseline CST and BCVA to those at each post-baseline visit to see if brolucizumab 6 mg works to treat persistent DME. Participants will: Receive brolucizumab 6 mg via intravitreal injections following two treatment patterns: Treatment Pattern 1: every 6 weeks for 5 injections Treatment Pattern 2: every 6 weeks for 3 injections followed by 1 injection after 12 weeks Visit the clinic 8 times for treatment and assessments over the course of 28 weeks

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edema; brolucizumab; central subfield thickness; visual acuity; anti-VEGF

Outcome Measures

Primary Outcomes (2)

• The proportion of patients with central subfield thickness (CST) <300 μm assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

  Central subfield thickness (CST) will be measured by Spectral Domain Optical Coherence Tomography (SD-OCT). The measurement of CST refers to the mean retinal thickness of the circular area within 1 mm in diameter that centered on the fovea. SD-OCT images will be captured for the study eye using SD-OCT equipment.

  Baseline, week 28

• The proportion of patients with best-corrected visual acuity (BCVA) improvement of ≥5 letters assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing chartstesting charts

  Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Eligible participants will be those with a BCVA ETDRS letter score ranging from 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye. The scoring system for visual function ranges from 0 to 100, with higher score indicating better visual function.

  Baseline, week 28

Secondary Outcomes (12)

• Change in BCVA at each post-baseline visit assessed by ETDRS visual acuity testing charts

  Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28

• The proportion of patients with gain in BCVA of ≥5, ≥10 and ≥15 letters assessed by ETDRS visual acuity testing charts

  Baseline, week 28

• The proportion of patients with loss in BCVA of ≥5, ≥10 and ≥15 letters assessed by ETDRS visual acuity testing charts

  Baseline, week 28

• Change in CST from baseline at each post-baseline visit assessed by SD-OCT

  Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28

• The proportion of patients with CST <280 μm assessed by SD-OCT at each post-baseline visit

  Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28

Other Outcomes (3)

• Change in aqueous cytokine levels assessed by immunological methods from baseline

  immediately before the first injection at week 1, immediately before the last injection at week 24

• Longitudinal changes of leakage in UWFFA

  Baseline, week 28

• Imaging predictors in SD-OCT: disorganization of retinal inner layers (DRIL), hyperreflective foci (HRF), integrity of the ellipsoid zone (EZ), IRF volume, SRF volume

  Baseline, week 28

Study Arms (1)

Brolucizumab 6mg

EXPERIMENTAL

Brolucizumab 6 mg will be given via intravitreal injections following two treatment patterns: Treatment pattern 1: q6w\*5; Treatment pattern 2: q6w\*3 +q12w\*1

Drug: intravitreal injection of Brolucizumab 6 mg in study eye

Interventions

intravitreal injection of Brolucizumab 6 mg in study eye DRUG

After disinfecting the conjunctival sac and administering a topical anesthetic, an intravitreal injection of Brolucizumab at a dose of 6 mg is given.

Brolucizumab 6mg

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 had to be obtained prior to participation in the study.
• Patients ≥18 years of age at screening.
• Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening.
• Study Eye: Visual impairment due to DME with: (1) BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts at a starting testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening and baseline. (2)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 SD-OCT at screening. (Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality) (3) Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCTs. (4) Diagnosis of DME less than 6 months prior to enrollment. (5) Have at least 3 intravitreal injections of the same anti-VEGF medication (Ranibizumab, Aflibercept, or Conbercept) within the 20 weeks prior to enrollment.

You may not qualify if:

• Active Proliferative Diabetic Retinopathy 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 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, or any history of intraocular inflammation.
• Presence of amblyopia, amaurosis or ocular disorders with vision \<20/200 (35 letters) in the fellow eye at screening or baseline.
• History of idiopathic or autoimmune uveitis in the study eye.
• Any history of intravitreal anti-VEGF treatment in study eye during the 28 days prior to baseline.
• Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 months prior to baseline.
• History of vitreoretinal surgery in study eye.
• Stroke or myocardial infarction during the 6 month period prior to baseline.
• Any history of renal failure requiring dialysis or kidney transplantation or any history of kidney transplantation.
• Poor blood pressure control（SBP≥180 mmHg or DBP≥100 mmHg）
• Any history of systemic anti-VEGF treatment during the 3 months prior to baseline
• Pregnancy

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Beijing Novartis Pharma: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Huang Z, Hu Y, Shen C, Li J, Liang A, Fang Y, Zeng J, Liao H, Zheng C, Ouyang S, Hu Y, Cao D, Yu H. Brolucizumab efficacy and safety single-arm descriptive trial in patients with persistent diabetic macular edema (BEST study): protocol for a single-centre, open-label, single-arm clinical trial in China. BMJ Open. 2025 Jul 28;15(7):e099551. doi: 10.1136/bmjopen-2025-099551.

  PMID: 40721260 DERIVED

Study Officials

• Honghua Yu

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 12, 2024
• Study Start: July 10, 2024
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)