Trial · NCT00444600
Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema
NCT00444600, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2011-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema. Trials, record NCT00444600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00444600
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema
- NCT number
- NCT00444600
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 691 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Interventions
- Triamcinolone Acetonide + laser, Ranibizumab + laser, Sham injection + laser, Ranibizumab + deferred laser
- First posted
- 2007-03-08
- Last updated
- 2019-10-07
- Results first posted
- 2011-07-12
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity | from baseline to 1 Year | Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. |
| Primary | Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year | from baseline to 1 Year | Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. |
| Primary | Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline | from baseline to 1 Year | |
| Primary | Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema | from baseline to 1 Year | |
| Primary | Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score | from baseline to 1 Year | Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. |
| Primary | Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness | from baseline to 1 Year | Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. |
| Primary | Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity | from baseline to 1 Year | Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. |
| Primary | Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator | from baseline to 1 Year | Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. |
| Secondary | Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year | from baseline to 1 year | Negative change denotes an improvement. |
| Secondary | Number of Injections in First Year | from baseline to 1 year | Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year | from baseline to 1 year | microns | MEAN | |
| SECONDARY | Number of Injections in First Year | from baseline to 1 year | Sham+prompt laser group listed median excludes 56 eyes among 163 participants with 2 study eyes that were unmasked at baseline because the participant's other eye was in the ranibizumab+deferred laser group, precluding sham injections for the study eye assigned to sham+prompt laser. | Injections | MEDIAN |
| PRIMARY | Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity | from baseline to 1 Year | For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis. followed intention to treat principle. | Letters | MEAN |
| PRIMARY | Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year | from baseline to 1 Year | For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis. | Eyes | NUMBER |
| OTHER_PRE_SPECIFIED | Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year | 1 Year | Eyes | NUMBER | |
| OTHER_PRE_SPECIFIED | Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening | 1 Year | Eyes | NUMBER | |
| PRIMARY | Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline | from baseline to 1 Year | Letters | MEAN | |
| PRIMARY | Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema | from baseline to 1 Year | Letters | MEAN | |
| PRIMARY | Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score | from baseline to 1 Year | Letters | MEAN | |
| PRIMARY | Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness | from baseline to 1 Year | Letters | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group236
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year | Sham+Prompt Laser | -102 | Standard Deviation 151 | microns | |
| Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year | 0.5 mg Ranibizumab+Prompt Laser | -131 | Standard Deviation 129 | microns | |
| Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | -137 | Standard Deviation 136 | microns | |
| Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year | 4 mg Triamcinolone+Prompt Laser | -127 | Standard Deviation 140 | microns | |
| Number of Injections in First Year | Sham+Prompt Laser | 11 | Inter-Quartile Range 8 to 13 | Injections | |
| Number of Injections in First Year | 0.5 mg Ranibizumab+Prompt Laser | 8 | Inter-Quartile Range 6 to 10 | Injections | |
| Number of Injections in First Year | 0.5 mg Ranibizumab+Deferred Laser | 9 | Inter-Quartile Range 6 to 11 | Injections | |
| Number of Injections in First Year | 4 mg Triamcinolone+Prompt Laser | 3 | Inter-Quartile Range 2 to 4 | Injections | |
| Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity | Sham+Prompt Laser | 3 | Standard Deviation 13 | Letters | |
| Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity | 0.5 mg Ranibizumab+Prompt Laser | 9 | Standard Deviation 11 | Letters |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sham+Prompt Laser | 293 | |
| Overall Study | STARTED | 0.5 mg Ranibizumab+Prompt Laser | 187 | |
| Overall Study | STARTED | 0.5 mg Ranibizumab+Deferred Laser | 188 | |
| Overall Study | STARTED | 4 mg Triamcinolone+Prompt Laser | 186 | |
| Overall Study | COMPLETED | Sham+Prompt Laser | 274 | |
| Overall Study | COMPLETED | 0.5 mg Ranibizumab+Prompt Laser | 171 | |
| Overall Study | COMPLETED | 0.5 mg Ranibizumab+Deferred Laser | 178 | |
| Overall Study | COMPLETED | 4 mg Triamcinolone+Prompt Laser | 176 | |
| Overall Study | NOT COMPLETED | Sham+Prompt Laser | 19 | |
| Overall Study | NOT COMPLETED | 0.5 mg Ranibizumab+Prompt Laser | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events910
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 | Cataract | Eye disorders | Sham + Prompt Laser | 12 | 139 | |
| other | Cataract | Eye disorders | Ranibizumab + Prompt Laser | 9 | 97 | |
| other | Cataract | Eye disorders | Ranibizumab + Deferred Laser | 10 | 105 | |
| other | Cataract | Eye disorders | Triamcinolone + Prompt Laser | 31 | 145 | |
| other | Cataract | Eye disorders | Sham + Ranibizumab + Laser | 0 | 0 | |
| other | Cataract | Eye disorders | Sham + Ranibizumab + Deferred Laser | 0 | 0 | |
| other | Cataract | Eye disorders | Sham + Triamcinolone + Laser | 0 | 0 | |
| other | Cataract subcapsular | Eye disorders | Sham + Prompt Laser | 7 | 139 | |
| other | Cataract subcapsular | Eye disorders | Ranibizumab + Prompt Laser | 5 | 97 | |
| other | Cataract subcapsular | Eye disorders | Ranibizumab + Deferred Laser | 4 | 105 |
1 to 10 of 910Source ClinicalTrials.gov
See all 910 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sham + Prompt Laser | ||
| Total, all-cause mortality | Ranibizumab + Prompt Laser | ||
| Total, all-cause mortality | Ranibizumab + Deferred Laser | ||
| Total, all-cause mortality | Triamcinolone + Prompt Laser | ||
| Total, all-cause mortality | Sham + Ranibizumab + Laser | ||
| Total, all-cause mortality | Sham + Ranibizumab + Deferred Laser | ||
| Total, all-cause mortality | Sham + Triamcinolone + Laser | ||
| Total, other adverse events | Sham + Prompt Laser | 139 | 139 |
| Total, other adverse events | Ranibizumab + Prompt Laser | 97 | 97 |
| Total, other adverse events | Ranibizumab + Deferred Laser | 105 | 105 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers17
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/NCT00444600
GET https://conductscience.org/api/trials/v1/NCT00444600/registered?page=2