Phase 3 N=689 Randomized Single-blind Treatment

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy

Bottom Line

View on ClinicalTrials.gov: NCT04278417 ↗

Enrolled (actual)

689

Serious AEs

29.2%

Results posted

Aug 2024

Primary outcome: Primary: Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye — 0.2; -4.2 Letters Read — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Brolucizumab 6 mg (Biological); Panretinal photocoagulation laser (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye	0.2; -4.2	<0.001 sig
SECONDARY Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye	187; 65	< 0.001 sig
SECONDARY Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye	188; 86	—
SECONDARY Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye	108; 248	< 0.001 sig
SECONDARY Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye	126; 262	—
SECONDARY Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye	0.5; -3.2; -0.1; -4.3	—
SECONDARY Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96	128; 57; 123; 65	<0.001 sig
SECONDARY Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96	6; 31; 18; 27	—
SECONDARY Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96	58; 30; 49; 33	—
SECONDARY Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96	4; 16; 11; 16	—
SECONDARY Number and Percentage of Subjects Developing Vision-threatening Complications Associated With Diabetic Retinopathy up to Week 54 and up to Week 96	117; 258; 144; 270	—
SECONDARY Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye	152; 199; 38; 83; 26; 27	—
SECONDARY Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term	226; 217; 44; 47; 35; 24	—

Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Eligibility Criteria

Inclusion Criteria

Signed informed consent must be obtained prior to participation
Able to complete adequate fundus photographs and retinal images
Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
DM treatment stable for at least 3 months
PDR diagnosis with no previous PRP treatment in the study eye

Exclusion Criteria

Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
Presence of diabetic macular edema in the study eye
Active infection or inflammation in the study eye
Uncontrolled glaucoma (IOP greater than 25 mmHg)
Intravitreal anti-VEGF treatment within 6 months
Treatment with intraocular corticosteroids
End stage renal disease requiring dialysis or kidney transplant
Uncontrolled blood pressure
Systemic anti-VEGF therapy at any time

Other protocol-defined inclusion/exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04278417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.