Phase 3
Completed N=517
Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Diabetic Macular Edema
Source: ClinicalTrials.gov NCT03917472 ↗
Enrolled (actual)
517
Serious AEs
21.3%
Results posted
Apr 2022
Primary outcomePrimary: Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 — 12.2; 11.0 Scores on a scale — p=0.099
◆ Published Evidence
Established
37citations · ~12 / year
Efficacy and Safety of Brolucizumab for Diabetic Macular Edema: The KINGFISHER Randomized Clinical Trial.
Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).
Linked Publications
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Efficacy and Safety of Brolucizumab for Diabetic Macular Edema: The KINGFISHER Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 |
12.2; 11.0 | 0.099 |
| SECONDARY Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit |
-146.9; -119.5; -174.4; -144.1; -191.3; -156.7 | <0.001 sig |
| SECONDARY Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit |
23; 4; 31; 4; 38; 10 | <0.001 sig |
| SECONDARY Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye |
61; 9; 93; 24; 124; 33 | — |
| SECONDARY Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit |
0; 0; 6; 1; 18; 3 | — |
| SECONDARY Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit |
0.000; 0.000; 0.018; 0.006; 0.071; 0.024 | — |
| SECONDARY Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit |
0; 0; 14; 1; 54; 12 | — |
| SECONDARY Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit |
0.000; 0.000; 0.041; 0.006; 0.199; 0.076 | — |
| SECONDARY Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye |
5.7; 5.4; 7.7; 7.4; 9.1; 8.0 | — |
| SECONDARY Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 |
286; 127; 211; 95; 151; 69 | — |
| SECONDARY Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye |
56; 21; 82; 38; 95; 45 | 0.002 sig |
| SECONDARY Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye |
18; 8; 33; 16; 40; 18 | — |
| SECONDARY Anti-Drug Antibody (ADA): Frequency Distribution of Pre-existing ADA Status in the Brolucizumab Arm |
112; 230 | — |
| SECONDARY Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye |
105; 59; 10; 7; 9; 6 | — |
| SECONDARY Number of Subjects With Non-ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) |
209; 96 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent must be obtained prior to participation in the study.
- Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening.
- Study eye: Visual impairment due to DME with:
- Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters
- DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT)
Exclusion Criteria
- High-risk proliferative diabetic retinopathy (PDR) in the study eye
- Concomitant conditions or ocular disorders in the study eye which confound interpretation of study results, compromise visual acuity or require medical or surgical intervention
- Any active intraocular or periocular infection or active intraocular inflammation in the either eye
- Uncontrolled glaucoma in the study eye
- Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200
- Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline
- Use of intraocular or periocular corticosteroids in the study eye during the 6-month period prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline
- Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline
Data sourced from ClinicalTrials.gov (NCT03917472) and the linked publication. 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. Informational only — not medical advice.