Trial · NCT04423718
Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
NCT04423718, Phase 3, Completed, Bayer; results first posted 2023-09-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye. Trials, record NCT04423718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04423718
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
- NCT number
- NCT04423718
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,011 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Neovascular Age-Related Macular Degeneration
- Interventions
- Aflibercept High Dose VEGF Trap-Eye (BAY86-5321), Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
- First posted
- 2020-06-09
- Last updated
- 2025-08-29
- Other registries' IDs
- eudract:2019-003851-12
- Results first posted
- 2023-09-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48 | At baseline and Week 48 | Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best). |
| Secondary | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60 | At baseline and Week 60 | Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best). |
| Secondary | Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16 | At Week 16 | |
| Secondary | Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48 | At baseline and Week 48 | |
| Secondary | Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48 | At Week 48 | |
| Secondary | Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48 | At baseline and Week 48 | |
| Secondary | Change in Total Lesion Area From Baseline to Week 48 | At baseline and Week 48 | |
| Secondary | Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48 | At Week 48 | |
| Secondary | Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48 | At baseline and Week 48 | |
| Secondary | Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48 | At baseline and Week 48 | NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 BCVA Measured by the ETDRS Letter Score at Week 48 | At baseline and Week 48 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60 | At baseline and Week 60 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16 | At Week 16 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy.~The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to missing assessment at the respective visit. These participants with missing assessments were not included in the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48 | At baseline and Week 48 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.~The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to 1 participant per each treatment group with no post-baseline BCVA. These participants with missing assessments were not included in the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48 | At Week 48 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.~The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to 1 participant per each treatment group with no post-baseline BCVA. These participants with missing assessments were not included in the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48 | At baseline and Week 48 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. | mm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Total Lesion Area From Baseline to Week 48 | At baseline and Week 48 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. | mm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48 | At Week 48 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.~The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to missing assessments at the respective visit. These participants with missing assessments were not included in the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48 | At baseline and Week 48 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. | µm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48 | At baseline and Week 48 | Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. | scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group58
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 BCVA Measured by the ETDRS Letter Score at Week 48 | Aflibercept 2q8 | 7.03 | Standard Error 0.74 | scores on a scale | |
| Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48 | Aflibercept HDq12 | 6.06 | Standard Error 0.77 | scores on a scale | |
| Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48 | Aflibercept HDq16 | 5.89 | Standard Error 0.72 | scores on a scale | |
| Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60 | Aflibercept 2q8 | 7.23 | Standard Error 0.68 | scores on a scale | |
| Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60 | Aflibercept HDq12 | 6.37 | Standard Error 0.74 | scores on a scale | |
| Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60 | Aflibercept HDq16 | 6.31 | Standard Error 0.66 | scores on a scale | |
| Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16 | Aflibercept 2q8 | 51.6 | Percentage of participants | ||
| Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16 | Aflibercept HDq12 | 61.6 | Percentage of participants | ||
| Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16 | Aflibercept HDq16 | 65.0 | Percentage of participants | ||
| Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16 | All Aflibercept HD | 63.3 | Percentage of participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study | STARTED | Aflibercept 2q8 (Week 0-96) / HD (up to Week 156) | 336 | |
| Main Study | STARTED | Aflibercep HDq12 (Week 0-156) | 335 | |
| Main Study | STARTED | Aflibercept HDq16 (Week 0-156) | 338 | |
| Main Study | COMPLETED | Aflibercept 2q8 (Week 0-96) / HD (up to Week 156) | 286 | |
| Main Study | COMPLETED | Aflibercep HDq12 (Week 0-156) | 291 | |
| Main Study | COMPLETED | Aflibercept HDq16 (Week 0-156) | 292 | |
| Main Study | NOT COMPLETED | Aflibercept 2q8 (Week 0-96) / HD (up to Week 156) | 50 | |
| Main Study | NOT COMPLETED | Aflibercep HDq12 (Week 0-156) | 44 | |
| Main Study | NOT COMPLETED | Aflibercept HDq16 (Week 0-156) | 46 | |
| Extension Phase | STARTED | Aflibercept 2q8 (Week 0-96) / HD (up to Week 156) | 208 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,944
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 | Eye disorders | Aflibercept 2q8 (Week 0- 96) | 22 | 336 | 22 |
| other | Cataract | Eye disorders | Aflibercept HDq12 (Week 0- 96) | 29 | 335 | 29 |
| other | Cataract | Eye disorders | Aflibercept HDq16 (Week 0- 96) | 32 | 338 | 33 |
| other | Cataract | Eye disorders | All Aflibercept HD (Week 0- 96) | 61 | 673 | 62 |
| other | Cataract | Eye disorders | Aflibercept 2q8/HD (Week 0- 156) | 27 | 208 | 29 |
| other | Cataract | Eye disorders | Aflibercept HDq12 (Week 0- 156) | 34 | 210 | 37 |
| other | Cataract | Eye disorders | Aflibercept HDq16 (Week 0- 156) | 33 | 207 | 35 |
| other | Cataract | Eye disorders | All Aflibercept HD (Week 0- 156) | 67 | 417 | 72 |
| other | Retinal haemorrhage | Eye disorders | Aflibercept 2q8 (Week 0- 96) | 19 | 336 | 21 |
| other | Retinal haemorrhage | Eye disorders | Aflibercept HDq12 (Week 0- 96) | 16 | 335 | 16 |
1 to 10 of 1,944Source ClinicalTrials.gov
See all 1,944 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept 2q8 (Week 0- 96) | 12 | 336 |
| Total, all-cause mortality | Aflibercept HDq12 (Week 0- 96) | 11 | 335 |
| Total, all-cause mortality | Aflibercept HDq16 (Week 0- 96) | 7 | 338 |
| Total, all-cause mortality | All Aflibercept HD (Week 0- 96) | 18 | 673 |
| Total, all-cause mortality | Aflibercept 2q8/HD (Week 0- 156) | 4 | 208 |
| Total, all-cause mortality | Aflibercept HDq12 (Week 0- 156) | 7 | 210 |
| Total, all-cause mortality | Aflibercept HDq16 (Week 0- 156) | 2 | 207 |
| Total, all-cause mortality | All Aflibercept HD (Week 0- 156) | 9 | 417 |
| Total, other adverse events | Aflibercept 2q8 (Week 0- 96) | 179 | 336 |
| Total, other adverse events | Aflibercept HDq12 (Week 0- 96) | 163 | 335 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers6
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 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/NCT04423718
GET https://conductscience.org/api/trials/v1/NCT04423718/results?page=2