Trial · NCT00996437
Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
NCT00996437, Phase 2, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2013-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N). Trials, record NCT00996437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00996437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
- NCT number
- NCT00996437
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 261 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Vitreous Hemorrhage, Proliferative Diabetic Retinopathy
- Interventions
- Ranibizumab, Saline
- First posted
- 2009-10-16
- Last updated
- 2016-08-26
- Results first posted
- 2013-05-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment or "Failure" Defined as Vitrectomy | within 112 days of randomization | The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit. |
| Primary | Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Baseline to 16 weeks | |
| Secondary | Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy | within 112 days of randomization | The proportion of eyes with "complete" panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test. |
| Secondary | Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength | 4, 8 and 12 weeks | Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline. |
| Secondary | Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status | 4, 8 and 12 weeks | Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best. |
| Secondary | Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit | 4, 8 and 12 weeks | |
| Secondary | Severe Visual Acuity Loss (Defined as <20/200) | 4,8 and 12 weeks | |
| Secondary | Very Severe Visual Acuity Loss (Defined as <20/800) | 4,8 and 12 weeks |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment or Failure Defined as Vitrectomy | within 112 days of randomization | The primary analysis followed the intent-to-treat principle and included all randomized eyes. | percentage of participants | NUMBER |
| PRIMARY | Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Baseline to 16 weeks | Adverse events for each participants was collected throughout study duration. | participants | NUMBER |
| SECONDARY | Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy | within 112 days of randomization | The secondary analysis followed the intent-to-treat principle and included all randomized eyes. | percentage of eyes | NUMBER |
| SECONDARY | Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength | 4, 8 and 12 weeks | This analysis followed the intent-to-treat principle | percentage of eyes | NUMBER |
| SECONDARY | Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status | 4, 8 and 12 weeks | Number of participants with a complete 4 week visit, 8 and 12 week respectively and an available visual acuity measurement. | letter scores | MEAN |
| SECONDARY | Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit | 4, 8 and 12 weeks | This analysis followed the intent-to-treat principle. It includes all randomized eyes with a completed 4, 8 and 12 week visit respectively and an available visual acuity measure. | percentage of participants | NUMBER |
| SECONDARY | Severe Visual Acuity Loss (Defined as <20/200) | 4,8 and 12 weeks | Participant with a completed 4,8 and 12 week visit and an available visual acuity measurement were included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Very Severe Visual Acuity Loss (Defined as <20/800) | 4,8 and 12 weeks | Participants with a completed 4, 8 and 12 week visit respectively and an available visual acuity measurement were included in the analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment or Failure Defined as Vitrectomy | Ranibizumab | 12 | percentage of participants | ||
| Treatment or Failure Defined as Vitrectomy | Saline Injection | 17 | percentage of participants | ||
| Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Ranibizumab | Endophthalmitis | 0 | participants | |
| Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Saline Injection | Endophthalmitis | 1 | participants | |
| Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Ranibizumab | Traction and/or rhegmatogeneous retinal detachment | 10 | participants | |
| Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Saline Injection | Traction and/or rhegmatogeneous retinal detachment | 11 | participants | |
| Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Ranibizumab | Angle or iris neovascularization | 1 | participants | |
| Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Saline Injection | Angle or iris neovascularization | 4 | participants | |
| Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Ranibizumab | Neovascular glaucoma | 1 | participants | |
| Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) | Saline Injection | Neovascular glaucoma | 1 | participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab | 125 | |
| Overall Study | STARTED | Saline Injection | 136 | |
| Overall Study | COMPLETED | Ranibizumab | 120 | |
| Overall Study | COMPLETED | Saline Injection | 129 | |
| Overall Study | NOT COMPLETED | Ranibizumab | 5 | |
| Overall Study | NOT COMPLETED | Saline Injection | 7 |
Source ClinicalTrials.gov
Adverse events382
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 discomfort | Gastrointestinal disorders | Ranibizumab | 0 | 125 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Saline Injection | 1 | 136 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Ranibizumab | 0 | 125 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Saline Injection | 2 | 136 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Ranibizumab | 2 | 125 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Saline Injection | 3 | 136 | 3 |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Ranibizumab | 1 | 125 | 1 |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Saline Injection | 0 | 136 | 0 |
| other | Anterior chamber cell | Eye disorders | Ranibizumab | 1 | 125 | 1 |
| other | Anterior chamber cell | Eye disorders | Saline Injection | 0 | 136 | 0 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab | ||
| Total, all-cause mortality | Saline Injection | ||
| Total, other adverse events | Ranibizumab | 84 | 125 |
| Total, other adverse events | Saline Injection | 94 | 136 |
| Total, serious adverse events | Ranibizumab | 13 | 125 |
| Total, serious adverse events | Saline Injection | 23 | 136 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 |
|---|---|---|---|---|---|---|
| U10EY014231 | DIABETIC RETINOPATHY CLINICAL RESEARCH NETWORK COORDINATING CENTER | GLASSMAN, ADAM R | JAEB CENTER FOR HEALTH RESEARCH, INC. | NATIONAL EYE INSTITUTE | 2002 to 2018 | NIH RePORTER |
| U10EY018817 | Diabetic Retinopathy Clinical Research Network Operations Center | BRESSLER, NEIL MICHAEL | JOHNS HOPKINS UNIVERSITY | NATIONAL EYE INSTITUTE | 2009 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ranibizumab vs Saline Injection: serious adverse events |
Source 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/NCT00996437
GET https://conductscience.org/api/trials/v1/NCT00996437/results?page=2