Trial · NCT00509795
Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)
NCT00509795, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2012-04-16
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 NCT00509795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00509795
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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
- NCT00509795
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,217 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Macular Degeneration
- Interventions
- ranibizumab, aflibercept injection (VEGF Trap-Eye, BAY86-5321), aflibercept injection (VEGF Trap-Eye, BAY86-5321), aflibercept injection (VEGF Trap-Eye, BAY86-5321)
- First posted
- 2007-08-01
- Last updated
- 2012-12-28
- Results first posted
- 2012-04-16
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 Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | Baseline and at week 52 | Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline. |
| Secondary | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF | Baseline and at week 52 | Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning. |
| Secondary | Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF. | Baseline and at week 52 | Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning. |
| Secondary | Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF | Baseline and at 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 which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight. |
| 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 (mm\^2); 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 Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | Baseline and at week 52 | PPS population used for analysis. | percentage of patients | NUMBER |
| SECONDARY | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF | Baseline and at week 52 | FAS population used for analysis. | letters read | MEAN |
| SECONDARY | Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF. | Baseline and at week 52 | FAS population used for analysis. | percentage of patients | NUMBER |
| SECONDARY | Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF | Baseline and at Week 52 | FAS population used for analysis. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF) | Baseline and at week 52 | FAS population used for analysis. | mm^2 | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | Ranibizumab 0.5mg Q4 | 94.4 | 0 | percentage of patients | |
| Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 95.1 | 0 | percentage of patients | |
| Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 95.9 | 0 | percentage of patients | |
| Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 95.1 | 0 | percentage of patients | |
| Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) | Total | 95.1 | 0 | percentage of patients | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF | Ranibizumab 0.5mg Q4 | 8.1 | Standard Deviation 15.25 | letters read | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 10.9 | Standard Deviation 13.77 | letters read | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 6.9 | Standard Deviation 13.41 | letters read | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 7.9 | Standard Deviation 15.00 | letters read | |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF | Total | 8.5 | Standard Deviation 14.44 | letters read |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab 0.5mg Q4 | 306 | |
| Overall Study | STARTED | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 304 | |
| Overall Study | STARTED | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 304 | |
| Overall Study | STARTED | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 303 | |
| Overall Study | Patients Received Treatment (SAF) | Ranibizumab 0.5mg Q4 | 304 | |
| Overall Study | Patients Received Treatment (SAF) | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 304 | |
| Overall Study | Patients Received Treatment (SAF) | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 304 | |
| Overall Study | Patients Received Treatment (SAF) | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 303 | |
| Overall Study | Full Analysis Set (FAS) Population | Ranibizumab 0.5mg Q4 | 304 | |
| Overall Study | Full Analysis Set (FAS) Population | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 304 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,492
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 | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Ranibizumab 0.5mg Q4 | 17 | 304 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 18 | 304 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 17 | 304 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 8 | 303 | |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | Ranibizumab 0.5mg Q4 | 11 | 304 | |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 14 | 304 | |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 13 | 304 | |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 16 | 303 | |
| other | BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Ranibizumab 0.5mg Q4 | 5 | 304 | |
| other | BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 11 | 304 |
1 to 10 of 1,492Source ClinicalTrials.gov
See all 1,492 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 | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | ||
| Total, all-cause mortality | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | ||
| Total, all-cause mortality | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | ||
| Total, other adverse events | Ranibizumab 0.5mg Q4 | 261 | 304 |
| Total, other adverse events | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 254 | 304 |
| Total, other adverse events | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 262 | 304 |
| Total, other adverse events | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 258 | 303 |
| Total, serious adverse events | Ranibizumab 0.5mg Q4 | 94 | 304 |
| Total, serious adverse events | IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 70 | 304 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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.
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