Trial · NCT02434328
Efficacy and Safety of RTH258 Versus Aflibercept - Study 2
NCT02434328, Phase 3, Completed, Alcon Research; results first posted 2019-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of RTH258 Versus Aflibercept - Study 2. Trials, record NCT02434328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02434328
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of RTH258 Versus Aflibercept - Study 2
- NCT number
- NCT02434328
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,048 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Neovascular Age-Related Macular Degeneration, Choroidal Neovascularization
- Interventions
- Brolucizumab ophthalmic solution, Aflibercept ophthalmic solution
- First posted
- 2015-05-05
- Last updated
- 2025-01-16
- Other registries' IDs
- eudract:2014-004886-26
- Results first posted
- 2019-10-31
Source ClinicalTrials.gov
Registered outcomes32
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) (Letters Read) at Week 48 - Study Eye | Baseline, Week 48 | BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Secondary | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | Baseline, Weeks 36, 40, 44, 48 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Secondary | Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 | Weeks 16, 20, 28, 32, 40, 44, 48 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. |
| Secondary | Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Weeks 16, 20, 28, 32, 40, 44, 48 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. |
| Secondary | Proportion of Subjects With Positive q12 Treatment Status up to Week 96 | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. |
| Secondary | Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. |
| Secondary | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Secondary | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Secondary | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Secondary | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye | Baseline, Weeks 84, 88, 92, 96 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
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) (Letters Read) at Week 48 - Study Eye | Baseline, Week 48 | Full Analysis Set (FAS) - Last Observation Carried Forward (LOCF) | letters | MEAN |
| SECONDARY | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | Baseline, Weeks 36, 40, 44, 48 | FAS - LOCF | letters | MEAN |
| SECONDARY | Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 | Weeks 16, 20, 28, 32, 40, 44, 48 | FAS - efficacy/safety approach | proportion of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Weeks 16, 20, 28, 32, 40, 44, 48 | FAS - efficacy/safety approach | proportion of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Positive q12 Treatment Status up to Week 96 | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 | FAS - efficacy/safety approach | proportion of subjects | NUMBER |
| SECONDARY | Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 | FAS - efficacy/safety approach | proportion of subjects | NUMBER |
| SECONDARY | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | FAS - LOCF | letters | MEAN |
| SECONDARY | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | 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 | FAS - LOCF | letters | MEAN |
| SECONDARY | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 | FAS - LOCF | letters | MEAN |
| SECONDARY | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye | Baseline, Weeks 84, 88, 92, 96 | FAS - LOCF | letters | MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group729
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) (Letters Read) at Week 48 - Study Eye | Brolucizumab 6 mg | 6.9 | Standard Deviation 11.47 | letters | |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye | Aflibercept 2 mg | 7.6 | Standard Deviation 12.47 | letters | |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | Brolucizumab 6 mg | 6.6 | Standard Deviation 11.10 | letters | |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | Aflibercept 2 mg | 7.7 | Standard Deviation 11.81 | letters | |
| Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 | Brolucizumab 6 mg | 0.5101 | 95% Confidence Interval 0.4567 to 0.5610 | proportion of subjects | |
| Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Brolucizumab 6 mg | 0.8170 | 95% Confidence Interval 0.7582 to 0.8629 | proportion of subjects | |
| Proportion of Subjects With Positive q12 Treatment Status up to Week 96 | Brolucizumab 6 mg | 0.3856 | 95% Confidence Interval 0.3336 to 0.4372 | proportion of subjects | |
| Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Brolucizumab 6 mg | 0.6170 | 95% Confidence Interval 0.5465 to 0.6799 | proportion of subjects | |
| Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Brolucizumab 6 mg | Change from baseline at Week 4 | 3.7 | Standard Deviation 7.03 | letters |
| Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Aflibercept 2 mg | Change from baseline at Week 4 | 4.7 | Standard Deviation 7.62 | letters |
1 to 10 of 729Source ClinicalTrials.gov
See all 729 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brolucizumab 6 mg | 372 | |
| Overall Study | STARTED | Aflibercept 2 mg | 371 | |
| Overall Study | Randomized and Treated | Brolucizumab 6 mg | 370 | |
| Overall Study | Randomized and Treated | Aflibercept 2 mg | 369 | |
| Overall Study | COMPLETED | Brolucizumab 6 mg | 342 | |
| Overall Study | COMPLETED | Aflibercept 2 mg | 329 | |
| Overall Study | NOT COMPLETED | Brolucizumab 6 mg | 30 | |
| Overall Study | NOT COMPLETED | Aflibercept 2 mg | 42 |
Source ClinicalTrials.gov
Adverse events376
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 | Cataract - Fellow eye | Eye disorders | Brolucizumab 6mg | 7 | 370 | |
| other | Cataract - Fellow eye | Eye disorders | Aflibercept 2mg | 22 | 369 | |
| other | Cataract - Study eye | Eye disorders | Brolucizumab 6mg | 11 | 370 | |
| other | Cataract - Study eye | Eye disorders | Aflibercept 2mg | 43 | 369 | |
| other | Conjunctival haemorrhage - Study eye | Eye disorders | Brolucizumab 6mg | 17 | 370 | |
| other | Conjunctival haemorrhage - Study eye | Eye disorders | Aflibercept 2mg | 19 | 369 | |
| other | Eye pain - Study eye | Eye disorders | Brolucizumab 6mg | 13 | 370 | |
| other | Eye pain - Study eye | Eye disorders | Aflibercept 2mg | 19 | 369 | |
| other | Neovascular age-related macular degeneration - Fellow eye | Eye disorders | Brolucizumab 6mg | 31 | 370 | |
| other | Neovascular age-related macular degeneration - Fellow eye | Eye disorders | Aflibercept 2mg | 32 | 369 |
1 to 10 of 376Source ClinicalTrials.gov
See all 376 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brolucizumab 6mg | 4 | 370 |
| Total, all-cause mortality | Aflibercept 2mg | 7 | 369 |
| Total, other adverse events | Brolucizumab 6mg | 176 | 370 |
| Total, other adverse events | Aflibercept 2mg | 194 | 369 |
| Total, serious adverse events | Brolucizumab 6mg | 79 | 370 |
| Total, serious adverse events | Aflibercept 2mg | 89 | 369 |
Source ClinicalTrials.gov
Papers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brolucizumab 6mg vs Aflibercept 2mg: deaths from any cause | Trial comparisons |
| Brolucizumab 6mg vs Aflibercept 2mg: serious adverse events | 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/NCT02434328
GET https://conductscience.org/api/trials/v1/NCT02434328/registered?page=2