Trial · NCT03917472
Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
NCT03917472, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2022-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema. Trials, record NCT03917472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03917472
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
- NCT number
- NCT03917472
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 517 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Diabetic Macular Edema
- Interventions
- Brolucizumab, Aflibercept
- First posted
- 2019-04-17
- Last updated
- 2022-08-12
- Other registries' IDs
- eudract:2019-001004-37
- Results first posted
- 2022-04-21
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | Baseline, Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Secondary | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
| Secondary | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with simultaneous absence of SRF and IRF in the study eye by visit. Events and censoring after 52 weeks are included in week 52 row. |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. |
| 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 | Baseline, Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | Baseline, Week 52 | Full analysis set (FAS) - Last observation carried forward (LOCF) | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Full analysis set (FAS) - Last observation carried forward (LOCF) | μm | LEAST_SQUARES_MEAN |
| SECONDARY | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Full analysis set (FAS) - Last observation carried forward (LOCF). | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Full analysis set (FAS) - Last observation carried forward (LOCF) | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Full Analysis Set. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. | Participants | NUMBER |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Full Analysis Set. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. | Probability of absence of SRF/IRF | NUMBER |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Full Analysis Set | Participants | NUMBER |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Full Analysis Set | Probability of absence of DME | NUMBER |
| 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 | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Full analysis set (FAS) - Last observation carried forward (LOCF) | scores on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline, Week 52 | Full analysis set (FAS) - Last observation carried forward (LOCF) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group318
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | Brolucizumab 6mg q4w | 12.2 | 95% Confidence Interval 11.2 to 13.2 | Scores on a scale | |
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | Aflibercept 2mg q4w | 11.0 | 95% Confidence Interval 9.6 to 12.4 | Scores on a scale | |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Brolucizumab 6mg q4w | Week 4 | -146.9 | 95% Confidence Interval -157.9 to -136.0 | μm |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Aflibercept 2mg q4w | Week 4 | -119.5 | 95% Confidence Interval -135.1 to -103.9 | μm |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Brolucizumab 6mg q4w | Week 8 | -174.4 | 95% Confidence Interval -185.3 to -163.4 | μm |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Aflibercept 2mg q4w | Week 8 | -144.1 | 95% Confidence Interval -159.7 to -128.5 | μm |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Brolucizumab 6mg q4w | Week 12 | -191.3 | 95% Confidence Interval -201.8 to -180.8 | μm |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Aflibercept 2mg q4w | Week 12 | -156.7 | 95% Confidence Interval -171.7 to -141.8 | μm |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Brolucizumab 6mg q4w | Week 16 | -200.5 | 95% Confidence Interval -211.0 to -189.9 | μm |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Aflibercept 2mg q4w | Week 16 | -162.4 | 95% Confidence Interval -177.4 to -147.4 | μm |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brolucizumab 6mg q4w | 346 | |
| Overall Study | STARTED | Aflibercept 2mg q4w | 171 | |
| Overall Study | COMPLETED | Brolucizumab 6mg q4w | 311 | |
| Overall Study | COMPLETED | Aflibercept 2mg q4w | 156 | |
| Overall Study | NOT COMPLETED | Brolucizumab 6mg q4w | 35 | |
| Overall Study | NOT COMPLETED | Aflibercept 2mg q4w | 15 |
Source ClinicalTrials.gov
Adverse events450
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Brolucizumab 6mg | 8 | 346 | |
| other | Anaemia | Blood and lymphatic system disorders | Aflibercept 2mg | 4 | 171 | |
| other | Anaemia | Blood and lymphatic system disorders | Overall | 12 | 517 | |
| other | Cataract - Fellow eye | Eye disorders | Brolucizumab 6mg | 6 | 346 | |
| other | Cataract - Fellow eye | Eye disorders | Aflibercept 2mg | 4 | 171 | |
| other | Cataract - Fellow eye | Eye disorders | Overall | 10 | 517 | |
| other | Cataract - Study eye | Eye disorders | Brolucizumab 6mg | 9 | 346 | |
| other | Cataract - Study eye | Eye disorders | Aflibercept 2mg | 6 | 171 | |
| other | Cataract - Study eye | Eye disorders | Overall | 15 | 517 | |
| other | Conjunctival haemorrhage - Fellow eye | Eye disorders | Brolucizumab 6mg | 4 | 346 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brolucizumab 6mg | 7 | 346 |
| Total, all-cause mortality | Aflibercept 2mg | 5 | 171 |
| Total, all-cause mortality | Overall | 12 | 517 |
| Total, other adverse events | Brolucizumab 6mg | 144 | 346 |
| Total, other adverse events | Aflibercept 2mg | 92 | 171 |
| Total, other adverse events | Overall | 236 | 517 |
| Total, serious adverse events | Brolucizumab 6mg | 74 | 346 |
| Total, serious adverse events | Aflibercept 2mg | 36 | 171 |
| Total, serious adverse events | Overall | 110 | 517 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Brolucizumab 6mg q4w vs Aflibercept 2mg q4w: Number of Subjects With Non-ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03917472
GET https://conductscience.org/api/trials/v1/NCT03917472/results?page=2