Trial · NCT01627249
Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema
NCT01627249, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2015-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema. Trials, record NCT01627249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01627249
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema
- NCT number
- NCT01627249
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 660 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Diabetic Macular Edema
- Interventions
- 2.0 mg intravitreal aflibercept, 1.25 mg intravitreal bevacizumab, 0.3 mg intravitreal ranibizumab
- First posted
- 2012-06-25
- Last updated
- 2020-08-10
- Results first posted
- 2015-12-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year | Baseline to 1-year | Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. |
| Primary | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 | Baseline to 1-year | Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. |
| Primary | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 | Baseline to 1-year | Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. |
| Secondary | Overall Change in Optical Coherence Tomography Central Subfield Thickness | baseline to 1-year | All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center. Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes. |
| Secondary | Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69 | baseline to 1-year | All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center. Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes. |
| Secondary | Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69 | baseline to 1-year | All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center. Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes. |
| Secondary | Overall Change in Retinal Volume | Baseline to 1-year | Baseline volume values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 459 scans. One-year volume values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 472 scans. When calculating change in volume, measurements taken on the same machine at both visits were not converted, because the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in volume was calculated after converting either the baseline and/or follow-up value from Spectralis or Cirrus to a Stratus equivalent value in 17 eyes. |
| Secondary | Total Number of Injections Prior to 1 Year | Baseline to 1-year | Only includes participants that completed the 1 year visit |
| Secondary | Total Number of Laser Treatments | between 24 weeks and 1 year | Only includes participants that completed the 1 year visit. |
| Secondary | Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser | Baseline to 1-year |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year | Baseline to 1-year | Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end). | units on a scale | MEAN |
| SECONDARY | Overall Change in Optical Coherence Tomography Central Subfield Thickness | baseline to 1-year | In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year. | microns | MEAN |
| PRIMARY | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 | Baseline to 1-year | Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end). | units on a scale | MEAN |
| PRIMARY | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 | Baseline to 1-year | Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end). | units on a scale | MEAN |
| SECONDARY | Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69 | baseline to 1-year | In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year. | microns | MEAN |
| SECONDARY | Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69 | baseline to 1-year | In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year. | microns | MEAN |
| SECONDARY | Overall Change in Retinal Volume | Baseline to 1-year | In addition to participants missing the 1-year visit, 46 in the aflibercept group, 53 in the bevacizumab group, and 44 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year. | mm^3 | MEAN |
| SECONDARY | Total Number of Injections Prior to 1 Year | Baseline to 1-year | Seven study eyes received 1 injection and 2 eyes received 2 injections of 0.5 mg of ranibizumab prior to the FDA approving a 0.3 mg dosage of ranibizumab for diabetic macular edema treatment. | Injections | MEAN |
| SECONDARY | Total Number of Laser Treatments | between 24 weeks and 1 year | participants | NUMBER | |
| SECONDARY | Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser | Baseline to 1-year | Eyes | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year | Aflibercept | 13.3 | Standard Deviation 11.1 | units on a scale | |
| Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year | Bevacizumab | 9.7 | Standard Deviation 10.1 | units on a scale | |
| Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year | Ranibizumab | 11.2 | Standard Deviation 9.4 | units on a scale | |
| Overall Change in Optical Coherence Tomography Central Subfield Thickness | Aflibercept | -169 | Standard Deviation 138 | microns | |
| Overall Change in Optical Coherence Tomography Central Subfield Thickness | Bevacizumab | -101 | Standard Deviation 121 | microns | |
| Overall Change in Optical Coherence Tomography Central Subfield Thickness | Ranibizumab | -147 | Standard Deviation 137 | microns | |
| Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 | Aflibercept | 18.9 | Standard Deviation 11.5 | units on a scale | |
| Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 | Bevacizumab | 11.8 | Standard Deviation 12.0 | units on a scale | |
| Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 | Ranibizumab | 14.2 | Standard Deviation 10.6 | units on a scale | |
| Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 | Aflibercept | 8.0 | Standard Deviation 7.6 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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 | 224 | |
| Overall Study | STARTED | Bevacizumab | 218 | |
| Overall Study | STARTED | Ranibizumab | 218 | |
| Overall Study | COMPLETED | Aflibercept | 208 | |
| Overall Study | COMPLETED | Bevacizumab | 206 | |
| Overall Study | COMPLETED | Ranibizumab | 206 | |
| Overall Study | NOT COMPLETED | Aflibercept | 16 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 12 | |
| Overall Study | NOT COMPLETED | Ranibizumab | 12 |
Source ClinicalTrials.gov
Adverse events489
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 | 14 | 224 | 17 |
| other | Cataract | Eye disorders | Bevacizumab | 11 | 218 | 14 |
| other | Cataract | Eye disorders | Ranibizumab | 14 | 218 | 16 |
| other | Conjunctival haemorrhage | Eye disorders | Aflibercept | 30 | 224 | 67 |
| other | Conjunctival haemorrhage | Eye disorders | Bevacizumab | 42 | 218 | 83 |
| other | Conjunctival haemorrhage | Eye disorders | Ranibizumab | 25 | 218 | 55 |
| other | Dry eye | Eye disorders | Aflibercept | 14 | 224 | 23 |
| other | Dry eye | Eye disorders | Bevacizumab | 9 | 218 | 15 |
| other | Dry eye | Eye disorders | Ranibizumab | 13 | 218 | 18 |
| other | Eye irritation | Eye disorders | Aflibercept | 13 | 224 | 28 |
1 to 10 of 489Source ClinicalTrials.gov
See all 489 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept | ||
| Total, all-cause mortality | Bevacizumab | ||
| Total, all-cause mortality | Ranibizumab | ||
| Total, other adverse events | Aflibercept | 152 | 224 |
| Total, other adverse events | Bevacizumab | 151 | 218 |
| Total, other adverse events | Ranibizumab | 144 | 218 |
| Total, serious adverse events | Aflibercept | 61 | 224 |
| Total, serious adverse events | Bevacizumab | 46 | 218 |
| Total, serious adverse events | Ranibizumab | 57 | 218 |
Source ClinicalTrials.gov
Papers22
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/NCT01627249
GET https://conductscience.org/api/trials/v1/NCT01627249/results?page=2