Trial · NCT05850520
A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
NCT05850520, Phase 3, Completed, Bayer; results first posted 2025-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion). Trials, record NCT05850520. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05850520
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
- NCT number
- NCT05850520
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 892 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Macular Edema Secondary to Retinal Vein Occlusion
- Interventions
- Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose, Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg, Sham, Fluorescein
- First posted
- 2023-05-09
- Last updated
- 2026-06-17
- Results first posted
- 2025-12-18
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 BCVA Measured by the ETDRS Letter Score at Week 36 | At Week 36 | BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity) |
| Secondary | Number of Active Injections From Baseline to Week 64 | From baseline to Week 64 | Active injections refer to the number of injections that were actually administered, as opposed to the number of planned injections. |
| Secondary | Number of Active Injections From Baseline to Week 36 | From baseline to Week 36 | Active injections refer to the number of injections that were actually administered, as opposed to the number of planned injections. |
| Secondary | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 44* | At Week 44 | BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity). \*This endpoint was only measured for the 8q8/5 and 2q4 groups |
| Secondary | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 64 | At Week 64 | BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity) |
| Secondary | Participants Gaining at Least 15 Letters in BCVA From Baseline at Weeks 36 and 64 | From baseline at Weeks 36 and 64 | |
| Secondary | Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Weeks 36 and 64 | At Weeks 36 and 64 | ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity) |
| Secondary | Participants Having no Intraretinal Fluid (IRF) and no Sub-retinal Fluid (SRF) in the Center Subfield at Weeks 36 and 64 | At Weeks 36 and 64 | Number of participants with no retinal fluid (no IRF and no SRF) in the central subfield at Weeks 36 and 64 |
| Secondary | Change From Baseline in Central Sub-field Thickness (CST) at Week 36 | From baseline to Week 36 | |
| Secondary | Change From Baseline in Central Sub-field Thickness (CST) at Week 64 | From baseline to Week 64 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes10
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 36 | At Week 36 | Full analysis set (FAS): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once. | Letters | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Active Injections From Baseline to Week 36 | From baseline to Week 36 | Full analysis set (FAS): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once. | Number of active injections | LEAST_SQUARES_MEAN |
| SECONDARY | Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 36 | From baseline at Week 36 | Full analysis set (FAS): All participants randomly assigned and exposed to study intervention (active or sham injection) at least once.~The Overall Number of Participants Analyzed differs from the Overall Number of Baseline Participants because only observed cases were used, excluding data after an intercurrent event (ICE) (e.g., stopping intervention or using prohibited medication before Week 36). Missing cases were not included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 36 | At Week 36 | Full analysis set (FAS): All participants randomly assigned and exposed to study intervention (active or sham injection) at least once.~The Overall Number of Participants Analyzed differs from the Overall Number of Baseline Participants because only observed cases were used, excluding data after an intercurrent event (ICE) (e.g., stopping intervention or using prohibited medication before Week 36). Missing cases were not included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Having no Intraretinal Fluid (IRF) and no Sub-retinal Fluid (SRF) in the Center Subfield at Week 36 | At Week 36 | Full analysis set (FAS): All participants randomly assigned and exposed to study intervention (active or sham injection) at least once.~The Overall Number of Participants Analyzed differs from the Overall Number of Baseline Participants because only observed cases were used, excluding data after an intercurrent event (ICE) (e.g., stopping intervention or using prohibited medication before Week 36). Missing cases were not included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Central Sub-field Thickness (CST) at Week 36 | From baseline to Week 36 | Full analysis set (FAS): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once. | μm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in NEI VFQ 25 Total Score at Week 36 | From baseline to Week 36 | Full analysis set (FAS): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Participants Dosed Only Q8 Through Week 36 in the 8 mg Q8 Group | Through Week 36 | SAF: All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once. Analysis of the SAF was performed according to the treatment the participant actually received (as treated).~The Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants because only participants considered as completers for Week 36 were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Weeks 36 | Through Week 36 | Safety analysis set (SAF): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once. Analysis of the SAF was performed according to the treatment the participant actually received (as treated). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Weeks 36 | From baseline through Week 36 | Pharmacokinetic analysis set (PKS): All participants randomly assigned to study intervention with at least one non-missing PK result after the first dose of study intervention. | ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group47
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 36 | Aflibercept 2q4 | 17.5 | Standard Error 0.7 | Letters | |
| Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 36 | Aflibercept 8q8/3 | 17.4 | Standard Error 0.7 | Letters | |
| Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 36 | Aflibercept 8q8/5 | 18.3 | Standard Error 0.6 | Letters | |
| Number of Active Injections From Baseline to Week 36 | Aflibercept 2q4 | 8.8 | Standard Error 0.0 | Number of active injections | |
| Number of Active Injections From Baseline to Week 36 | Aflibercept 8q8/3 | 6.1 | Standard Error 0.0 | Number of active injections | |
| Number of Active Injections From Baseline to Week 36 | Aflibercept 8q8/5 | 6.9 | Standard Error 0.0 | Number of active injections | |
| Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 36 | Aflibercept 2q4 | 158 | Participants | ||
| Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 36 | Aflibercept 8q8/3 | 153 | Participants | ||
| Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 36 | Aflibercept 8q8/5 | 161 | Participants | ||
| Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 36 | Aflibercept 2q4 | 179 | Participants |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aflibercept 2q4 | 301 | |
| Overall Study | STARTED | Aflibercept 8q8/3 | 293 | |
| Overall Study | STARTED | Aflibercept 8q8/5 | 298 | |
| Overall Study | COMPLETED | Aflibercept 2q4 | 287 | |
| Overall Study | COMPLETED | Aflibercept 8q8/3 | 278 | |
| Overall Study | COMPLETED | Aflibercept 8q8/5 | 273 | |
| Overall Study | NOT COMPLETED | Aflibercept 2q4 | 14 | |
| Overall Study | NOT COMPLETED | Aflibercept 8q8/3 | 15 | |
| Overall Study | NOT COMPLETED | Aflibercept 8q8/5 | 25 |
Source ClinicalTrials.gov
Adverse events2,308
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 | Aflibercept 2q4 | 2 | 301 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Aflibercept 8q8/3 | 2 | 293 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Aflibercept 8q8/5 | 1 | 298 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | All Aflibercept 8 mg | 3 | 591 | 3 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Aflibercept 2q4 | 1 | 301 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Aflibercept 8q8/3 | 1 | 293 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Aflibercept 8q8/5 | 0 | 298 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | All Aflibercept 8 mg | 1 | 591 | 1 |
| other | Lymphocytosis | Blood and lymphatic system disorders | Aflibercept 2q4 | 0 | 301 | 0 |
| other | Lymphocytosis | Blood and lymphatic system disorders | Aflibercept 8q8/3 | 1 | 293 | 1 |
1 to 10 of 2,308Source ClinicalTrials.gov
See all 2,308 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept 2q4 | 2 | 301 |
| Total, all-cause mortality | Aflibercept 8q8/3 | 2 | 293 |
| Total, all-cause mortality | Aflibercept 8q8/5 | 3 | 298 |
| Total, all-cause mortality | All Aflibercept 8 mg | 5 | 591 |
| Total, other adverse events | Aflibercept 2q4 | 188 | 301 |
| Total, other adverse events | Aflibercept 8q8/3 | 184 | 293 |
| Total, other adverse events | Aflibercept 8q8/5 | 176 | 298 |
| Total, other adverse events | All Aflibercept 8 mg | 360 | 591 |
| Total, serious adverse events | Aflibercept 2q4 | 32 | 301 |
| Total, serious adverse events | Aflibercept 8q8/3 | 23 | 293 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT05850520
GET https://conductscience.org/api/trials/v1/NCT05850520/results?page=2