Trial · NCT01969708
Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)
NCT01969708, Phase 3, Completed, The Emmes Company, LLC; results first posted 2018-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2). Trials, record NCT01969708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01969708
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)
- NCT number
- NCT01969708
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 362 participants, actual
- Lead sponsor
- The Emmes Company, LLC
- Conditions
- Central Retinal Vein Occlusion
- Interventions
- aflibercept, bevacizumab
- First posted
- 2013-10-25
- Last updated
- 2021-06-22
- Results first posted
- 2018-08-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6 | Month 0 to 6 | The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent. |
| Secondary | Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6 | Month 0 to 6 | The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6 |
| Secondary | Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6 | Month 0 to 6 | The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6 |
| Secondary | Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness | Month 0 to 6 | The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography |
| Secondary | Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6 | Month 0 to 6 | The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness |
| Secondary | Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces | Month 0 to 6 | The measure is the number of study eyes with central subfield thickness \<300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6 | Month 0 to 6 | All participants with visual acuity letter score recorded at Month 6 | letters read | MEAN |
| SECONDARY | Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6 | Month 0 to 6 | All participants with visual acuity letter score recorded at Month 6 | study eyes | NUMBER |
| SECONDARY | Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6 | Month 0 to 6 | All participants with visual acuity letter score recorded at Month 6 | study eyes | NUMBER |
| SECONDARY | Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness | Month 0 to 6 | All participants with central subfield thickness recorded at baseline and Month 6 | um | MEAN |
| SECONDARY | Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6 | Month 0 to 6 | All participants with central subfield thickness recorded at baseline and Month 6 | um | MEAN |
| SECONDARY | Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces | Month 0 to 6 | All participants with central subfield thickness recorded at Month 6 | study eyes | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6 | Aflibercept | 18.9 | 95% Confidence Interval 16.62 to 21.15 | letters read | |
| Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6 | Bevacizumab | 18.6 | 95% Confidence Interval 16.16 to 21.09 | letters read | |
| Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6 | Aflibercept | 114 | study eyes | ||
| Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6 | Bevacizumab | 106 | study eyes | ||
| Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6 | Aflibercept | 101 | study eyes | ||
| Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6 | Bevacizumab | 99 | study eyes | ||
| Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness | Aflibercept | 231.3 | 95% Confidence Interval 220.8 to 241.8 | um | |
| Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness | Bevacizumab | 287.9 | 95% Confidence Interval 269.4 to 306.4 | um | |
| Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6 | Aflibercept | -425 | 95% Confidence Interval -461 to -389 | um | |
| Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6 | Bevacizumab | -387 | 95% Confidence Interval -426 to -348 | um |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aflibercept | 180 | |
| Overall Study | STARTED | Bevacizumab | 182 | |
| Overall Study | COMPLETED | Aflibercept | 175 | |
| Overall Study | COMPLETED | Bevacizumab | 173 | |
| Overall Study | NOT COMPLETED | Aflibercept | 5 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 9 |
Source ClinicalTrials.gov
Adverse events420
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 | Abdominal pain | Gastrointestinal disorders | Aflibercept | 0 | 180 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab | 1 | 182 | 1 |
| other | Acarodermatitis | Infections and infestations | Aflibercept | 0 | 180 | 0 |
| other | Acarodermatitis | Infections and infestations | Bevacizumab | 1 | 182 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Aflibercept | 1 | 180 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Bevacizumab | 2 | 182 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Aflibercept | 1 | 180 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Bevacizumab | 0 | 182 | 0 |
| other | Aneurysm | Vascular disorders | Aflibercept | 0 | 180 | 0 |
| other | Aneurysm | Vascular disorders | Bevacizumab | 1 | 182 | 1 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept | 1 | 180 |
| Total, all-cause mortality | Bevacizumab | 1 | 182 |
| Total, other adverse events | Aflibercept | 82 | 180 |
| Total, other adverse events | Bevacizumab | 98 | 182 |
| Total, serious adverse events | Aflibercept | 14 | 180 |
| Total, serious adverse events | Bevacizumab | 14 | 182 |
Source ClinicalTrials.gov
Papers20
The papers the trial lists on ClinicalTrials.gov.
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10EY023521 | SCORE2 Comparative Trial (SCT) | BLODI, BARBARA A | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL EYE INSTITUTE | 2013 to 2018 | NIH RePORTER |
| U10EY023529 | SCORE2 Comparative Trial (SCT) | VAN VELDHUISEN, PAUL C | THE EMMES COMPANY, LLC | NATIONAL EYE INSTITUTE | 2013 to 2018 | NIH RePORTER |
| U10EY023533 | SCORE2 Comparative Trial (SCT) | SCOTT, INGRID U | PENNSYLVANIA STATE UNIV HERSHEY MED CTR | NATIONAL EYE INSTITUTE | 2013 to 2018 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aflibercept vs Bevacizumab: deaths from any cause | Trial comparisons |
| Aflibercept vs Bevacizumab: serious adverse events | Trial comparisons |
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/NCT01969708
GET https://conductscience.org/api/trials/v1/NCT01969708/events?page=2