Trial · NCT04005352
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
NCT04005352, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON). Trials, record NCT04005352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04005352
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
- NCT number
- NCT04005352
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 734 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Age-related Macular Degeneration
- Interventions
- Brolucizumab 6 mg, Aflibercept 2 mg
- First posted
- 2019-07-02
- Last updated
- 2024-10-09
- Other registries' IDs
- eudract:2019-000716-28
- Results first posted
- 2024-01-30
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | Up to Week 32 | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. Intraretinal Fluid (IRF), Subretinal Fluid (SRF), hemorrhage, leakage, etc.). Treatment interval distribution. Number (%) of subjects at 12/8/4-weeks intervals up to Week 32 for the study eye. If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or ≥12-week then the floor value of these ranges was used. |
| Primary | Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye | Baseline, Week 28 and Week 32 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. Least squares mean estimate - for weeks 28 and 32 combined. |
| Secondary | Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye | Up to Week 64 | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). Treatment interval distribution. The number of subjects at 16/12/8/4-weeks intervals as the last interval with no disease activity. If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or (12-weeks, 16-weeks) or ≥16-week then the floor value of these ranges was used. |
| Secondary | Distribution of the Maximal Intervals With no Disease Activity up to Week 64 - Study Eye | Up to Week 64 | No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). Maximal interval distribution. Number of subjects at 16/12/8/4-weeks intervals as the last interval with no disease activity. If the study treatment is discontinued before Week 16 included, then the treatment interval is 4 weeks; otherwise, the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the maximal interval falls within the following ranges of \[4-weeks, 8-weeks) or \[8-weeks, 12-weeks) or \[12-weeks, 16-weeks\] or ≥16-weeks then the floor value of these ranges is used. |
| Secondary | Number of Participants With no Disease Activity - Study Eye | Weeks 14 and 16 | Disease activity assessment as determined by visual acuity and assessment of other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.). |
| Secondary | Time From Last Loading Injection to First Visit With No Disease Activity (Weeks) - 75th Percentile - Study Eye | Up to Week 64 | Intraretinal fluid (IRF) and subretinal fluid (SRF) were assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye). Please note that this endpoint can be impacted by the optional disease activity assessment visits and the flexible dosing regimen, in addition to the randomized treatment. Hence, the observed treatment effect may be confounded by the study design artifacts. |
| Secondary | Time-to-first Dry Retina - Time to the First Visit With no Intraretinal Fluid (IRF) or Subretinal Fluid (SRF) - Study Eye | Up to Week 64 | Intraretinal fluid (IRF) and subretinal fluid (SRF) were assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye). |
| Secondary | Average Change From Baseline at Week 60 and Week 64 in Best-corrected Visual Acuity (BCVA) - Study Eye | Baseline, Week 60 and Week 64 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. Least squares mean estimate - for weeks 60 and 64 combined. |
| Secondary | Number of Participants With Best-corrected Visual Acuity Improvements of ≥ 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters up to Week 32/64 Per Treatment Arm - Study Eye | Baseline, Week 32, and Week 64 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
| Secondary | Number of Participants With Best-corrected Visual Acuity ≥ 69 Letters - Study Eye | Week 32 and Week 64 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | Up to Week 32 | Full Analysis Set (Includes participants who were randomized and treated.) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye | Baseline, Week 28 and Week 32 | Full Analysis Set - Last observation carried forward (LOCF). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye | Up to Week 64 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distribution of the Maximal Intervals With no Disease Activity up to Week 64 - Study Eye | Up to Week 64 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With no Disease Activity - Study Eye | Weeks 14 and 16 | Full Analysis Set. Note that the number analyzed is reduced because the Week 14 visit was conducted at the investigator's discretion, and because some patients had already stopped treatment by Week 16. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Last Loading Injection to First Visit With No Disease Activity (Weeks) - 75th Percentile - Study Eye | Up to Week 64 | Full Analysis Set - subjects with no important protocol deviations with impact | weeks | NUMBER |
| SECONDARY | Time-to-first Dry Retina - Time to the First Visit With no Intraretinal Fluid (IRF) or Subretinal Fluid (SRF) - Study Eye | Up to Week 64 | Full Analysis Set - subjects with no important protocol deviations with impact | Participants | NUMBER |
| SECONDARY | Average Change From Baseline at Week 60 and Week 64 in Best-corrected Visual Acuity (BCVA) - Study Eye | Baseline, Week 60 and Week 64 | Full Analysis Set - LOCF | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Best-corrected Visual Acuity Improvements of ≥ 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters up to Week 32/64 Per Treatment Arm - Study Eye | Baseline, Week 32, and Week 64 | Full Analysis Set - LOCF | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Best-corrected Visual Acuity ≥ 69 Letters - Study Eye | Week 32 and Week 64 | Full Analysis Set - LOCF | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | Brolucizumab 6 mg | 12 weeks | 141 | Participants | |
| Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | Aflibercept 2 mg | 12 weeks | 73 | Participants | |
| Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | Brolucizumab 6 mg | 8 weeks | 131 | Participants | |
| Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | Aflibercept 2 mg | 8 weeks | 147 | Participants | |
| Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | Brolucizumab 6 mg | 4 weeks | 94 | Participants | |
| Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye | Aflibercept 2 mg | 4 weeks | 148 | Participants | |
| Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye | Brolucizumab 6 mg | 5.2 | Standard Error 0.51 | Scores on a scale | |
| Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye | Aflibercept 2 mg | 5.1 | Standard Error 0.51 | Scores on a scale | |
| Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye | Brolucizumab 6 mg | 16 Weeks | 104 | Participants | |
| Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye | Aflibercept 2 mg | 16 Weeks | 45 | Participants |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 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 6 mg | 366 | |
| Overall Study | STARTED | Aflibercept 2 mg | 368 | |
| Overall Study | COMPLETED | Brolucizumab 6 mg | 317 | |
| Overall Study | COMPLETED | Aflibercept 2 mg | 307 | |
| Overall Study | NOT COMPLETED | Brolucizumab 6 mg | 49 | |
| Overall Study | NOT COMPLETED | Aflibercept 2 mg | 61 |
Source ClinicalTrials.gov
Adverse events495
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 | 0 | 366 | |
| other | Anaemia | Blood and lymphatic system disorders | Aflibercept 2mg | 4 | 368 | |
| other | Anaemia | Blood and lymphatic system disorders | All Patients | 4 | 734 | |
| other | Atrial fibrillation | Cardiac disorders | Brolucizumab 6mg | 6 | 366 | |
| other | Atrial fibrillation | Cardiac disorders | Aflibercept 2mg | 1 | 368 | |
| other | Atrial fibrillation | Cardiac disorders | All Patients | 7 | 734 | |
| other | Vertigo | Ear and labyrinth disorders | Brolucizumab 6mg | 4 | 366 | |
| other | Vertigo | Ear and labyrinth disorders | Aflibercept 2mg | 4 | 368 | |
| other | Vertigo | Ear and labyrinth disorders | All Patients | 8 | 734 | |
| other | Cataract - Study Eye | Eye disorders | Brolucizumab 6mg | 5 | 366 |
1 to 10 of 495Source ClinicalTrials.gov
See all 495 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brolucizumab 6mg | 4 | 366 |
| Total, all-cause mortality | Aflibercept 2mg | 2 | 368 |
| Total, all-cause mortality | All Patients | 6 | 734 |
| Total, other adverse events | Brolucizumab 6mg | 172 | 366 |
| Total, other adverse events | Aflibercept 2mg | 177 | 368 |
| Total, other adverse events | All Patients | 349 | 734 |
| Total, serious adverse events | Brolucizumab 6mg | 58 | 366 |
| Total, serious adverse events | Aflibercept 2mg | 53 | 368 |
| Total, serious adverse events | All Patients | 111 | 734 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Brolucizumab 6 mg vs Aflibercept 2 mg: Number of Participants With Treatment Emergent Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) - Summary Table |
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/NCT04005352
GET https://conductscience.org/api/trials/v1/NCT04005352/registered?page=2