Trial · NCT00745498
Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy
NCT00745498, Not applicable, Completed, Seoul National University Bundang Hospital; results first posted 2015-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy. Trials, record NCT00745498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00745498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy
- NCT number
- NCT00745498
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 126 participants, actual
- Lead sponsor
- Seoul National University Bundang Hospital
- Conditions
- Proliferative Diabetic Retinopathy, Vitreous Hemorrhage
- Interventions
- Bevacizumab
- First posted
- 2008-09-03
- Last updated
- 2015-12-21
- Results first posted
- 2015-12-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrent VH Incidence (Early and Late) | 6 months | Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. "Early recurrent VH" was VH occurring \<= 4 weeks and "late recurrent VH" was VH occurring \>4 weeks after surgery. |
| Secondary | Initial Time of Vitreous Clearing (ITVC) | 6 months | The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels. |
| Secondary | Visual Outcome | 6 months | Best-corrected visual acuity (BCVA) at postoperative 6 months |
| Secondary | Postoperative Resolution of Neovascularization | 6 months |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrent VH Incidence (Early and Late) | 6 months | With study power of 80%, significance level of 0.05, assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated. The ITT approach was used for analysis. | Percentage of participants | NUMBER |
| SECONDARY | Initial Time of Vitreous Clearing (ITVC) | 6 months | days | MEAN | |
| SECONDARY | Visual Outcome | 6 months | logMAR | MEAN | |
| SECONDARY | Postoperative Resolution of Neovascularization | 6 months |
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 |
|---|---|---|---|---|---|
| Recurrent VH Incidence (Early and Late) | Preop IVB | Early | 22.2 | Percentage of participants | |
| Recurrent VH Incidence (Early and Late) | Intraop IVB | Early | 10.8 | Percentage of participants | |
| Recurrent VH Incidence (Early and Late) | No IVB | Early | 32.4 | Percentage of participants | |
| Recurrent VH Incidence (Early and Late) | Preop IVB | Late | 11.1 | Percentage of participants | |
| Recurrent VH Incidence (Early and Late) | Intraop IVB | Late | 16.2 | Percentage of participants | |
| Recurrent VH Incidence (Early and Late) | No IVB | Late | 14.7 | Percentage of participants | |
| Initial Time of Vitreous Clearing (ITVC) | Preop IVB | 26.4 | Standard Deviation 42.5 | days | |
| Initial Time of Vitreous Clearing (ITVC) | Intraop IVB | 10.3 | Standard Deviation 8.2 | days | |
| Initial Time of Vitreous Clearing (ITVC) | No IVB | 25.2 | Standard Deviation 26.1 | days | |
| Visual Outcome | Preop IVB | 0.62 | Standard Deviation 0.58 | logMAR |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Preop IVB | 41 | |
| Overall Study | STARTED | Introp IVB | 43 | |
| Overall Study | STARTED | No IVB | 42 | |
| Overall Study | COMPLETED | Preop IVB | 36 | |
| Overall Study | COMPLETED | Introp IVB | 37 | |
| Overall Study | COMPLETED | No IVB | 34 | |
| Overall Study | NOT COMPLETED | Preop IVB | 5 | |
| Overall Study | NOT COMPLETED | Introp IVB | 6 | |
| Overall Study | NOT COMPLETED | No IVB | 8 |
Source ClinicalTrials.gov
Adverse events6
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 | neovascular glaucoma following surgery | Eye disorders | Preop IVB | 1 | 41 | 1 |
| other | neovascular glaucoma following surgery | Eye disorders | Intraop IVB | 3 | 43 | 3 |
| other | neovascular glaucoma following surgery | Eye disorders | No IVB | 1 | 42 | 1 |
| serious | Rhegmatogenous retinal detachment immediately following operation | Eye disorders | Preop IVB | 0 | 41 | 0 |
| serious | Rhegmatogenous retinal detachment immediately following operation | Eye disorders | Intraop IVB | 0 | 43 | 0 |
| serious | Rhegmatogenous retinal detachment immediately following operation | Eye disorders | No IVB | 1 | 42 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Preop IVB | ||
| Total, all-cause mortality | Intraop IVB | ||
| Total, all-cause mortality | No IVB | ||
| Total, other adverse events | Preop IVB | 1 | 41 |
| Total, other adverse events | Intraop IVB | 3 | 43 |
| Total, other adverse events | No IVB | 1 | 42 |
| Total, serious adverse events | Preop IVB | 0 | 41 |
| Total, serious adverse events | Intraop IVB | 0 | 43 |
| Total, serious adverse events | No IVB | 1 | 42 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 16829817 | BACKGROUND |
Source PubMed
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/NCT00745498
GET https://conductscience.org/api/trials/v1/NCT00745498/registered