Trial · NCT00637377
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
NCT00637377, Phase 3, Completed, Bayer; results first posted 2012-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD). Trials, record NCT00637377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00637377
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
- NCT number
- NCT00637377
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,240 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Macular Degeneration
- Interventions
- Ranibizumab, Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321), Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321), Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
- First posted
- 2008-03-18
- Last updated
- 2014-12-12
- Other registries' IDs
- eudract:2007-000583-25
- Results first posted
- 2012-01-23
- Limitations and caveats
- The conditional sequence of hypothesis testing had to stop after testing the first superiority hypothesis. Therefore, all further statistical tests are exploratory tests.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | At week 52 | Maintenance of vision was defined as a loss of \< 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed. |
| Secondary | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF | Baseline and at week 52 | Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. |
| Secondary | Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF | At week 52 | Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed. |
| Secondary | Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF | Baseline and at week 52 | The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible). |
| Secondary | Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF | Baseline and at week 52 | CNV area values measured in square millimeters; lower values represent better outcomes. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | At week 52 | Per-Protocol Set (PPS); imputation technique: LOCF | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF | Baseline and at week 52 | Full-Analysis Set (FAS); imputation technique: LOCF | Letters correctly read | MEAN |
| SECONDARY | Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF | At week 52 | Full-Analysis Set; imputation technique: LOCF | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF | Baseline and at week 52 | Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF | Baseline and at week 52 | Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF | mm^2 | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | Ranibizumab 0.5mg Q4 | 94.42 | Percentage of participants | ||
| Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 95.62 | Percentage of participants | ||
| Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 96.27 | Percentage of participants | ||
| Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 95.56 | Percentage of participants | ||
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF | Ranibizumab 0.5mg Q4 | 9.4 | Standard Deviation 13.5 | Letters correctly read | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 7.6 | Standard Deviation 12.6 | Letters correctly read | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 9.7 | Standard Deviation 14.1 | Letters correctly read | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 8.9 | Standard Deviation 14.4 | Letters correctly read | |
| Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF | Ranibizumab 0.5mg Q4 | 34.02 | Percentage of participants | ||
| Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 29.45 | Percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab 0.5mg Q4 | 303 | |
| Overall Study | STARTED | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 313 | |
| Overall Study | STARTED | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 311 | |
| Overall Study | STARTED | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 313 | |
| Overall Study | Participants Received Treatment | Ranibizumab 0.5mg Q4 | 291 | |
| Overall Study | Participants Received Treatment | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 309 | |
| Overall Study | Participants Received Treatment | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 297 | |
| Overall Study | Participants Received Treatment | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 307 | |
| Overall Study | Participants Treated (FAS) | Ranibizumab 0.5mg Q4 | 291 | |
| Overall Study | Participants Treated (FAS) | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 309 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,276
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 | Atrioventricular block first degree | Cardiac disorders | Ranibizumab 0.5mg Q4 | 16 | 291 | |
| other | Atrioventricular block first degree | Cardiac disorders | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 25 | 309 | |
| other | Atrioventricular block first degree | Cardiac disorders | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 23 | 297 | |
| other | Atrioventricular block first degree | Cardiac disorders | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 22 | 307 | |
| other | Cataract | Eye disorders | Ranibizumab 0.5mg Q4 | 29 | 291 | |
| other | Cataract | Eye disorders | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 36 | 309 | |
| other | Cataract | Eye disorders | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 34 | 297 | |
| other | Cataract | Eye disorders | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 32 | 307 | |
| other | Conjunctival haemorrhage | Eye disorders | Ranibizumab 0.5mg Q4 | 34 | 291 | |
| other | Conjunctival haemorrhage | Eye disorders | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 33 | 309 |
1 to 10 of 1,276Source ClinicalTrials.gov
See all 1,276 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab 0.5mg Q4 | ||
| Total, all-cause mortality | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | ||
| Total, all-cause mortality | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | ||
| Total, all-cause mortality | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | ||
| Total, other adverse events | Ranibizumab 0.5mg Q4 | 254 | 291 |
| Total, other adverse events | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 259 | 309 |
| Total, other adverse events | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 251 | 297 |
| Total, other adverse events | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 260 | 307 |
| Total, serious adverse events | Ranibizumab 0.5mg Q4 | 65 | 291 |
| Total, serious adverse events | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 81 | 309 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT00637377
GET https://conductscience.org/api/trials/v1/NCT00637377/events?page=2