Trial · NCT02858076
Anti-VEGF vs. Prompt Vitrectomy for VH From PDR
NCT02858076, Phase 2, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2021-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anti-VEGF vs. Prompt Vitrectomy for VH From PDR. Trials, record NCT02858076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02858076
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-VEGF vs. Prompt Vitrectomy for VH From PDR
- NCT number
- NCT02858076
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 205 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Proliferative Diabetic Retinopathy, Vitreous Hemorrhage
- Interventions
- 2-mg Intravitreous Aflibercept Injection, Prompt Vitrectomy Plus Panretinal Photocoagulation
- First posted
- 2016-08-08
- Last updated
- 2021-04-20
- Results first posted
- 2021-01-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 24 weeks | The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | E-ETDRS Visual Acuity Letter Score | 4 Weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | E-ETDRS Visual Acuity Letter Score | 12 Weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | E-ETDRS Visual Acuity Letter Score | 24 Weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | E-ETDRS Visual Acuity Letter Score | 1-Year from participant randomization | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | E-ETDRS Visual Acuity Letter Score | 2 Years | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 2-Years | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | Snellen Equivalent Range (Visual Acuity Score) | 4 weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | Snellen Equivalent Range (Visual Acuity Score) | 12 weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Secondary | Snellen Equivalent Range (Visual Acuity Score) | 24 weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 24 weeks | units on a scale | MEAN | |
| SECONDARY | E-ETDRS Visual Acuity Letter Score | 4 Weeks | units on a scale | MEAN | |
| SECONDARY | E-ETDRS Visual Acuity Letter Score | 12 Weeks | units on a scale | MEAN | |
| SECONDARY | E-ETDRS Visual Acuity Letter Score | 24 Weeks | units on a scale | MEAN | |
| SECONDARY | E-ETDRS Visual Acuity Letter Score | 1-Year from participant randomization | units on a scale | MEAN | |
| SECONDARY | E-ETDRS Visual Acuity Letter Score | 2 Years | units on a scale | MEAN | |
| SECONDARY | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 2-Years | units on a scale | MEAN | |
| SECONDARY | Snellen Equivalent Range (Visual Acuity Score) | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Snellen Equivalent Range (Visual Acuity Score) | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Snellen Equivalent Range (Visual Acuity Score) | 24 weeks | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | Intravitreous 2 mg Aflibercept Injections | 59.3 | Standard Deviation 21.9 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | Prompt Vitrectomy Plus Panretinal Photocoagulation | 63.0 | Standard Deviation 21.7 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score | Intravitreous 2 mg Aflibercept Injections | 52.6 | Standard Deviation 29.4 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score | Vitrectomy With Panretinal Photocoagulation | 62.3 | Standard Deviation 26.8 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score | Intravitreous 2 mg Aflibercept Injections | 63.7 | Standard Deviation 25.0 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score | Prompt Vitrectomy Plus Panretinal Photocoagulation | 67.3 | Standard Deviation 24.7 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score | Intravitreous 2 mg Aflibercept Injections | 69.4 | Standard Deviation 23.8 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score | Prompt Vitrectomy Plus Panretinal Photocoagulation | 69.0 | Standard Deviation 23.1 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score | Intravitreous 2 mg Aflibercept Injections | 70.5 | Standard Deviation 20.3 | units on a scale | |
| E-ETDRS Visual Acuity Letter Score | Prompt Vitrectomy Plus Panretinal Photocoagulation | 72.7 | Standard Deviation 20.3 | units on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravitreous 2 mg Aflibercept Injections | 100 | |
| Overall Study | STARTED | Vitrectomy With Panretinal Photocoagulation | 105 | |
| Overall Study | COMPLETED | Intravitreous 2 mg Aflibercept Injections | 90 | |
| Overall Study | COMPLETED | Vitrectomy With Panretinal Photocoagulation | 87 | |
| Overall Study | NOT COMPLETED | Intravitreous 2 mg Aflibercept Injections | 10 | |
| Overall Study | NOT COMPLETED | Vitrectomy With Panretinal Photocoagulation | 18 |
Source ClinicalTrials.gov
Adverse events1,102
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 | Anemia | Blood and lymphatic system disorders | Intravitreous 2 mg Aflibercept Injections | 4 | 100 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Prompt Vitrectomy Plus Panretinal Photocoagulation | 7 | 105 | 8 |
| other | Anemia of chronic disease | Blood and lymphatic system disorders | Intravitreous 2 mg Aflibercept Injections | 1 | 100 | 1 |
| other | Anemia of chronic disease | Blood and lymphatic system disorders | Prompt Vitrectomy Plus Panretinal Photocoagulation | 1 | 105 | 1 |
| other | Anemia, unspecified | Blood and lymphatic system disorders | Intravitreous 2 mg Aflibercept Injections | 1 | 100 | 1 |
| other | Anemia, unspecified | Blood and lymphatic system disorders | Prompt Vitrectomy Plus Panretinal Photocoagulation | 0 | 105 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Intravitreous 2 mg Aflibercept Injections | 1 | 100 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Prompt Vitrectomy Plus Panretinal Photocoagulation | 1 | 105 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Intravitreous 2 mg Aflibercept Injections | 0 | 100 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Prompt Vitrectomy Plus Panretinal Photocoagulation | 1 | 105 | 1 |
1 to 10 of 1,102Source ClinicalTrials.gov
See all 1,102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravitreous 2 mg Aflibercept Injections | 6 | 100 |
| Total, all-cause mortality | Prompt Vitrectomy Plus Panretinal Photocoagulation | 3 | 105 |
| Total, other adverse events | Intravitreous 2 mg Aflibercept Injections | 97 | 100 |
| Total, other adverse events | Prompt Vitrectomy Plus Panretinal Photocoagulation | 98 | 105 |
| Total, serious adverse events | Intravitreous 2 mg Aflibercept Injections | 44 | 100 |
| Total, serious adverse events | Prompt Vitrectomy Plus Panretinal Photocoagulation | 45 | 105 |
Source ClinicalTrials.gov
Papers3
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intravitreous 2 mg Aflibercept Injections vs Prompt Vitrectomy Plus Panretinal Photocoagulation: Retinal Neovascularization on Clinical Exam | Trial comparisons |
| Intravitreous 2 mg Aflibercept Injections vs Prompt Vitrectomy Plus Panretinal Photocoagulation: Recurrent Vitreous Hemorrhage | Trial comparisons |
| Intravitreous 2 mg Aflibercept Injections vs Prompt Vitrectomy Plus Panretinal Photocoagulation: Retinal Neovascularization on Clinical Exam | Trial comparisons |
| Intravitreous 2 mg Aflibercept Injections vs Prompt Vitrectomy Plus Panretinal Photocoagulation: deaths from any cause | Trial comparisons |
| Intravitreous 2 mg Aflibercept Injections vs Prompt Vitrectomy Plus Panretinal Photocoagulation: Retinal Neovascularization on Clinical Exam | Trial comparisons |
| Intravitreous 2 mg Aflibercept Injections vs Prompt Vitrectomy Plus Panretinal Photocoagulation: 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.
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