Trial · NCT03710564
Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
NCT03710564, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2022-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections. Trials, record NCT03710564. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03710564
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
- NCT number
- NCT03710564
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 535 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Age-Related Macular Degeneration
- Interventions
- Brolucizumab, Aflibercept
- First posted
- 2018-10-18
- Last updated
- 2023-01-30
- Results first posted
- 2022-07-22
Source ClinicalTrials.gov
Registered outcomes17
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 was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. A positive change from baseline represents better functioning. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Secondary | Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Baseline, weeks 52 and 104 | Visual Acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. VA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of participants with no change or gain in VA compared to baseline was reported. VA stabilization or improvement is defined as a change from baseline no worse than 5 letters loss in VA compared to Baseline. Baseline VA was defined as the last measurement on or prior to the baseline visit. VA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Secondary | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Secondary | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Secondary | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Secondary | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Secondary | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Secondary | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Secondary | Change in Central Subfield Thickness (CST) From Baseline | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | CST was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A negative change from baseline is a favorable outcome. CST assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. |
| Secondary | Number of Participants With Intraretinal Fluid (IRF) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | IRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of IRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 | All randomized participants | Score on a scale | MEAN |
| SECONDARY | Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Baseline, weeks 52 and 104 | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Central Subfield Thickness (CST) From Baseline | Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | All randomized participants | µm | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Intraretinal Fluid (IRF) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group598
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 | 0.3 | Standard Deviation 9.02 | Score on a scale | |
| Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52 | Aflibercept | 0.9 | Standard Deviation 6.51 | Score on a scale | |
| Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Brolucizumab | Week 52 | 232 | Participants | |
| Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Aflibercept | Week 52 | 132 | Participants | |
| Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Brolucizumab | Week 104 | 122 | Participants | |
| Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Aflibercept | Week 104 | 63 | Participants | |
| Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Brolucizumab | Week 4 | 31 | Participants | |
| Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Aflibercept | Week 4 | 16 | Participants | |
| Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Brolucizumab | Week 8 | 38 | Participants | |
| Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Aflibercept | Week 8 | 17 | Participants |
1 to 10 of 598Source ClinicalTrials.gov
See all 598 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 | 356 | |
| Overall Study | STARTED | Aflibercept | 179 | |
| Overall Study | COMPLETED | Brolucizumab | 172 | |
| Overall Study | COMPLETED | Aflibercept | 86 | |
| Overall Study | NOT COMPLETED | Brolucizumab | 184 | |
| Overall Study | NOT COMPLETED | Aflibercept | 93 |
Source ClinicalTrials.gov
Adverse events906
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 | 4 | 356 | |
| other | Anaemia | Blood and lymphatic system disorders | Aflibercept 2mg | 6 | 179 | |
| other | Anaemia | Blood and lymphatic system disorders | Overall | 10 | 535 | |
| other | Arrhythmia | Cardiac disorders | Brolucizumab 6mg | 1 | 356 | |
| other | Arrhythmia | Cardiac disorders | Aflibercept 2mg | 2 | 179 | |
| other | Arrhythmia | Cardiac disorders | Overall | 3 | 535 | |
| other | Arteriosclerosis coronary artery | Cardiac disorders | Brolucizumab 6mg | 1 | 356 | |
| other | Arteriosclerosis coronary artery | Cardiac disorders | Aflibercept 2mg | 2 | 179 | |
| other | Arteriosclerosis coronary artery | Cardiac disorders | Overall | 3 | 535 | |
| other | Atrial fibrillation | Cardiac disorders | Brolucizumab 6mg | 9 | 356 |
1 to 10 of 906Source ClinicalTrials.gov
See all 906 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brolucizumab 6mg | 10 | 356 |
| Total, all-cause mortality | Aflibercept 2mg | 4 | 179 |
| Total, all-cause mortality | Overall | 14 | 535 |
| Total, other adverse events | Brolucizumab 6mg | 287 | 356 |
| Total, other adverse events | Aflibercept 2mg | 149 | 179 |
| Total, other adverse events | Overall | 436 | 535 |
| Total, serious adverse events | Brolucizumab 6mg | 75 | 356 |
| Total, serious adverse events | Aflibercept 2mg | 45 | 179 |
| Total, serious adverse events | Overall | 120 | 535 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03710564
GET https://conductscience.org/api/trials/v1/NCT03710564/results?page=2