Trial · NCT01331681
Intravitreal Aflibercept Injection in Vision Impairment Due to DME
NCT01331681, Phase 3, Completed, Bayer; results first posted 2014-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intravitreal Aflibercept Injection in Vision Impairment Due to DME. Trials, record NCT01331681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01331681
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intravitreal Aflibercept Injection in Vision Impairment Due to DME
- NCT number
- NCT01331681
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 406 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Diabetes Mellitus, Macular Edema
- Interventions
- VEGF Trap-Eye (BAY86-5321), VEGF Trap-Eye (BAY86-5321), Macular Laser Photocoagulation (Control)
- First posted
- 2011-04-08
- Last updated
- 2023-11-27
- Other registries' IDs
- eudract:2010-022364-12
- Results first posted
- 2014-09-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) | Baseline up to Week 52 | Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning. |
| Secondary | Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Baseline up to Week 52 | Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning. |
| Secondary | Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Baseline up to Week 52 | Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning. |
| Secondary | Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF | Baseline up to Week 52 | Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85) |
| Secondary | Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF | Baseline up to Week 52 | |
| Secondary | Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF | Baseline up to Week 52 | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. |
| Secondary | Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF | Baseline up to Week 52 | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. |
Source ClinicalTrials.gov
Outcomes7
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 (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) | Baseline up to Week 52 | Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA. | Letters correctly read | MEAN |
| SECONDARY | Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Baseline up to Week 52 | FAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Baseline up to Week 52 | FAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF | Baseline up to Week 52 | Full-Analysis Set with assessment for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF | Baseline up to Week 52 | Full-Analysis Set with assessment for this outcome measure. | micrometer | MEAN |
| SECONDARY | Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF | Baseline up to Week 52 | Full-Analysis Set with assessment for this outcome measure. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF | Baseline up to Week 52 | Full-Analysis Set with assessment for this outcome measure. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group21
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 (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) | Intravitreal Aflibercept Injection 2Q4 | 10.5 | Standard Deviation 9.55 | Letters correctly read | |
| Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) | Intravitreal Aflibercept Injection 2Q8 | 10.7 | Standard Deviation 9.32 | Letters correctly read | |
| Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) | Control | 1.2 | Standard Deviation 10.65 | Letters correctly read | |
| Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Intravitreal Aflibercept Injection 2Q4 | 54.4 | Percentage of participants | ||
| Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Intravitreal Aflibercept Injection 2Q8 | 53.3 | Percentage of participants | ||
| Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Control | 25.8 | Percentage of participants | ||
| Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Intravitreal Aflibercept Injection 2Q4 | 32.4 | Percentage of participants | ||
| Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Intravitreal Aflibercept Injection 2Q8 | 33.3 | Percentage of participants | ||
| Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF | Control | 9.1 | Percentage of participants | ||
| Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF | Intravitreal Aflibercept Injection 2Q4 | 33.3 | Percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravitreal Aflibercept Injection 2Q4 | 136 | |
| Overall Study | STARTED | Intravitreal Aflibercept Injection 2Q8 | 135 | |
| Overall Study | STARTED | Macular Laser Photocoagulation (Control) | 135 | |
| Overall Study | Participants Received Treatment | Intravitreal Aflibercept Injection 2Q4 | 136 | |
| Overall Study | Participants Received Treatment | Intravitreal Aflibercept Injection 2Q8 | 135 | |
| Overall Study | Participants Received Treatment | Macular Laser Photocoagulation (Control) | 133 | |
| Overall Study | Completed Week 52 | Intravitreal Aflibercept Injection 2Q4 | 125 | |
| Overall Study | Completed Week 52 | Intravitreal Aflibercept Injection 2Q8 | 121 | |
| Overall Study | Completed Week 52 | Macular Laser Photocoagulation (Control) | 115 | |
| Overall Study | Completed Week 100 | Intravitreal Aflibercept Injection 2Q4 | 115 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events693
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 | Intravitreal Aflibercept Injection 2Q4 | 6 | 136 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Intravitreal Aflibercept Injection 2Q8 | 3 | 135 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Macular Laser Photocoagulation (Control) | 8 | 133 | 8 |
| other | Cataract | Eye disorders | Intravitreal Aflibercept Injection 2Q4 | 31 | 136 | 43 |
| other | Cataract | Eye disorders | Intravitreal Aflibercept Injection 2Q8 | 26 | 135 | 37 |
| other | Cataract | Eye disorders | Macular Laser Photocoagulation (Control) | 17 | 133 | 29 |
| other | Cataract cortical | Eye disorders | Intravitreal Aflibercept Injection 2Q4 | 7 | 136 | 12 |
| other | Cataract cortical | Eye disorders | Intravitreal Aflibercept Injection 2Q8 | 6 | 135 | 7 |
| other | Cataract cortical | Eye disorders | Macular Laser Photocoagulation (Control) | 1 | 133 | 3 |
| other | Cataract subcapsular | Eye disorders | Intravitreal Aflibercept Injection 2Q4 | 11 | 136 | 16 |
1 to 10 of 693Source ClinicalTrials.gov
See all 693 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravitreal Aflibercept Injection 2Q4 | ||
| Total, all-cause mortality | Intravitreal Aflibercept Injection 2Q8 | ||
| Total, all-cause mortality | Macular Laser Photocoagulation (Control) | ||
| Total, other adverse events | Intravitreal Aflibercept Injection 2Q4 | 117 | 136 |
| Total, other adverse events | Intravitreal Aflibercept Injection 2Q8 | 122 | 135 |
| Total, other adverse events | Macular Laser Photocoagulation (Control) | 113 | 133 |
| Total, serious adverse events | Intravitreal Aflibercept Injection 2Q4 | 63 | |
| Total, serious adverse events | Intravitreal Aflibercept Injection 2Q8 | 60 | |
| Total, serious adverse events | Macular Laser Photocoagulation (Control) | 51 |
Source ClinicalTrials.gov
Papers12
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/NCT01331681
GET https://conductscience.org/api/trials/v1/NCT01331681/results?page=2