Trial · NCT00445003
Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
NCT00445003, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2011-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy. Trials, record NCT00445003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00445003
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
- NCT number
- NCT00445003
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 333 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Proliferative Diabetic Retinopathy, Diabetic Macular Edema
- Interventions
- Ranibizumab, Triamcinolone Acetonide, Sham injection, Focal/grid laser
- First posted
- 2007-03-08
- Last updated
- 2016-08-26
- Results first posted
- 2011-07-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks | baseline to 14 weeks | 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 | Additional Treatments for Diabetic Macular Edema | 14 weeks to 56-weeks | Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments. |
| Secondary | Change in Optical Coherence Tomography Central Subfield Thickness | Baseline to 14 weeks | |
| Secondary | Total Optical Coherence Tomography Retinal Volume | Baseline to 14-weeks | Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons. |
| Secondary | Change in Visual Acuity From Baseline | baseline to 56-weeks | 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 | Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema | 14 weeks to 56-weeks | |
| Secondary | Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema | 14 weeks to 56-weeks | Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments. |
| Secondary | Change in Optical Coherence Tomography Retinal Volume | Baseline to 14 weeks | Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively |
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 | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks | baseline to 14 weeks | Participants with 2 study eyes enrolled each eye in a different arm. Each arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. Analysis followed intention to treat principle; eyes without 14-week data, the Last Observation Carried Forward method was used. | Letter Score | MEAN |
| SECONDARY | Additional Treatments for Diabetic Macular Edema | 14 weeks to 56-weeks | Eyes | NUMBER | |
| SECONDARY | Change in Optical Coherence Tomography Central Subfield Thickness | Baseline to 14 weeks | Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. | Microns | MEDIAN |
| SECONDARY | Total Optical Coherence Tomography Retinal Volume | Baseline to 14-weeks | Participants with 2 study eyes enrolled each eye in a different arm. Therefore, each arm includes no more than 1 eye for a given participant, and thus the numbers of eyes is equal to number of participants. | mm^3 | MEAN |
| SECONDARY | Change in Visual Acuity From Baseline | baseline to 56-weeks | Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. | Letter Score | MEAN |
| SECONDARY | Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema | 14 weeks to 56-weeks | Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. | Eyes | NUMBER |
| SECONDARY | Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema | 14 weeks to 56-weeks | Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. | Eyes | NUMBER |
| SECONDARY | Change in Optical Coherence Tomography Retinal Volume | Baseline to 14 weeks | Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. | mm^3 | MEAN |
Source ClinicalTrials.gov
Results by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks | Sham Injection | -4 | Standard Deviation 14 | Letter Score | |
| Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks | 0.5mg Ranibizumab | 1 | Standard Deviation 11 | Letter Score | |
| Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks | 4-mg Triamcinolone Acetonided | 2 | Standard Deviation 11 | Letter Score | |
| Additional Treatments for Diabetic Macular Edema | Sham Injection | Bevacizumab | 14 | Eyes | |
| Additional Treatments for Diabetic Macular Edema | 0.5mg Ranibizumab | Bevacizumab | 12 | Eyes | |
| Additional Treatments for Diabetic Macular Edema | 4-mg Triamcinolone Acetonided | Bevacizumab | 9 | Eyes | |
| Additional Treatments for Diabetic Macular Edema | Sham Injection | Ranibizumab | 1 | Eyes | |
| Additional Treatments for Diabetic Macular Edema | 0.5mg Ranibizumab | Ranibizumab | 0 | Eyes | |
| Additional Treatments for Diabetic Macular Edema | 4-mg Triamcinolone Acetonided | Ranibizumab | 3 | Eyes | |
| Additional Treatments for Diabetic Macular Edema | Sham Injection | Triamcinolone | 3 | Eyes |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sham Injection | 123 | |
| Overall Study | STARTED | 0.5mg Ranibizumab | 113 | |
| Overall Study | STARTED | 4-mg Triamcinolone Acetonided | 109 | |
| Overall Study | COMPLETED | Sham Injection | 118 | |
| Overall Study | COMPLETED | 0.5mg Ranibizumab | 103 | |
| Overall Study | COMPLETED | 4-mg Triamcinolone Acetonided | 105 | |
| Overall Study | NOT COMPLETED | Sham Injection | 5 | |
| Overall Study | NOT COMPLETED | 0.5mg Ranibizumab | 10 | |
| Overall Study | NOT COMPLETED | 4-mg Triamcinolone Acetonided | 4 |
Source ClinicalTrials.gov
Adverse events111
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 | Conjunctival haemorrhage | Eye disorders | Sham Injection | 2 | 133 | |
| other | Conjunctival haemorrhage | Eye disorders | 0.5mg Ranibizumab | 11 | 116 | |
| other | Conjunctival haemorrhage | Eye disorders | 4-mg Triamcinolone Acetonided | 8 | 115 | |
| other | Eye pain | Eye disorders | Sham Injection | 11 | 133 | |
| other | Eye pain | Eye disorders | 0.5mg Ranibizumab | 7 | 116 | |
| other | Eye pain | Eye disorders | 4-mg Triamcinolone Acetonided | 6 | 115 | |
| other | headache | General disorders | Sham Injection | 7 | 133 | |
| other | headache | General disorders | 0.5mg Ranibizumab | 7 | 116 | |
| other | headache | General disorders | 4-mg Triamcinolone Acetonided | 5 | 115 | |
| other | Intraocular pressure increase | Eye disorders | Sham Injection | 1 | 133 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sham Injection | ||
| Total, all-cause mortality | 0.5mg Ranibizumab | ||
| Total, all-cause mortality | 4-mg Triamcinolone Acetonided | ||
| Total, other adverse events | Sham Injection | 57 | 133 |
| Total, other adverse events | 0.5mg Ranibizumab | 50 | 116 |
| Total, other adverse events | 4-mg Triamcinolone Acetonided | 66 | 115 |
| Total, serious adverse events | Sham Injection | 11 | 133 |
| Total, serious adverse events | 0.5mg Ranibizumab | 15 | 116 |
| Total, serious adverse events | 4-mg Triamcinolone Acetonided | 12 | 115 |
Source ClinicalTrials.gov
Papers14
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 |
|---|---|---|---|---|---|---|
| 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 |
| U10EY014229 | Diabetic Retinopathy Clinical Research Network | DANIS, RONALD | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL EYE INSTITUTE | 2002 to 2008 | NIH RePORTER |
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/NCT00445003
GET https://conductscience.org/api/trials/v1/NCT00445003/results?page=2