Trial · NCT00367133

Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema

NCT00367133, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2010-07-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema. Trials, record NCT00367133. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00367133

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema
NCT number: NCT00367133
Status: Completed
Phases: Phase 3
Enrollment: 840 participants, actual
Lead sponsor: Jaeb Center for Health Research
Conditions: Diabetic Macular Edema
Interventions: Standard of Care Group, 1mg triamcinolone acetonide, 4mg triamcinolone acetonide
First posted: 2006-08-22
Last updated: 2016-08-26
Results first posted: 2010-07-09

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.	Baseline to 2 Years	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	Median Change in Visual Acuity Baseline to 2 Years	Baseline to 2 Years	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.
Primary	Distribution of Change in Visual Acuity Baseline to 2 Years	baseline to 2 years	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.
Secondary	Central Subfield Thickness at 2 Years	2 Years	Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Secondary	Mean Change in Central Subfield Thickness Baseline to 2 Years	Baseline to 2 years	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.
Secondary	Median Change in Central Subfield Thickness Baseline to 2 Years	Baseline to 2 Years	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Secondary	Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years	Baseline to 2 Years	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Secondary	Central Subfield Thickness < 250 Microns at 2 Years	2 Years	Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Secondary	Change in Visual Acuity From Baseline to 3 Years	Baseline to 3 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.
Secondary	Change in Visual Acuity From Baseline to 3 Years	Baseline to 3 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 Value=0

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.	Baseline to 2 Years	The primary analysis included all randomized eyes and followed the intent-to-treat principle.	Letter score	MEAN
SECONDARY	Central Subfield Thickness at 2 Years	2 Years	Only subjects with an available Optical coherence tomography (OCT) at baseline and 2 years are included in the OCT analysis.	Microns	MEDIAN
PRIMARY	Median Change in Visual Acuity Baseline to 2 Years	Baseline to 2 Years	The primary analysis included all randomized eyes and followed the intent-to-treat principle.	Letter score	MEDIAN
PRIMARY	Distribution of Change in Visual Acuity Baseline to 2 Years	baseline to 2 years	The primary analysis included all randomized eyes and followed the intent-to-treat principle	Percentage of Eyes	NUMBER
SECONDARY	Mean Change in Central Subfield Thickness Baseline to 2 Years	Baseline to 2 years	Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.	Microns	MEAN
SECONDARY	Median Change in Central Subfield Thickness Baseline to 2 Years	Baseline to 2 Years	Only subjects with an available OCT's at baseline and 2 years are included in the OCT analysis.	Microns	MEDIAN
SECONDARY	Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years	Baseline to 2 Years	Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.	Percentage of Eyes	NUMBER
SECONDARY	Central Subfield Thickness < 250 Microns at 2 Years	2 Years	Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.	Percentage of Eyes	NUMBER
SECONDARY	Change in Visual Acuity From Baseline to 3 Years	Baseline to 3 year	The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.	Letter Score	MEAN
SECONDARY	Change in Visual Acuity From Baseline to 3 Years	Baseline to 3 year	The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.	Letter Score	MEDIAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group81

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.	Focal/Grid Laser Photocoagulation		1	Standard Deviation 17	Letter score
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.	1mg Intravitreal Triamcinolone		-2	Standard Deviation 18	Letter score
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.	4 mg Intravitreal Triamcinolone		-3	Standard Deviation 22	Letter score
Central Subfield Thickness at 2 Years	Focal/Grid Laser Photocoagulation		243	Inter-Quartile Range 148	Microns
Central Subfield Thickness at 2 Years	1mg Intravitreal Triamcinolone		305	Inter-Quartile Range 167	Microns
Central Subfield Thickness at 2 Years	4 mg Intravitreal Triamcinolone		279	Inter-Quartile Range 160	Microns
Median Change in Visual Acuity Baseline to 2 Years	Focal/Grid Laser Photocoagulation		4	Inter-Quartile Range -6 to 11	Letter score
Median Change in Visual Acuity Baseline to 2 Years	1mg Intravitreal Triamcinolone		1	Inter-Quartile Range -11 to 9	Letter score
Median Change in Visual Acuity Baseline to 2 Years	4 mg Intravitreal Triamcinolone		2	Inter-Quartile Range -11 to 11	Letter score
Distribution of Change in Visual Acuity Baseline to 2 Years	Focal/Grid Laser Photocoagulation	>= 15 letter improvement	18		Percentage of Eyes

1 to 10 of 81Source ClinicalTrials.gov

See all 81 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
2 Years	STARTED	Focal/Grid Laser Photocoagulation	330
2 Years	STARTED	1mg Intravitreal Triamcinolone	256
2 Years	STARTED	4 mg Intravitreal Triamcinolone	254
2 Years	COMPLETED	Focal/Grid Laser Photocoagulation	272
2 Years	COMPLETED	1mg Intravitreal Triamcinolone	220
2 Years	COMPLETED	4 mg Intravitreal Triamcinolone	205
2 Years	NOT COMPLETED	Focal/Grid Laser Photocoagulation	58
2 Years	NOT COMPLETED	1mg Intravitreal Triamcinolone	36
2 Years	NOT COMPLETED	4 mg Intravitreal Triamcinolone	49
3 Years	STARTED	Focal/Grid Laser Photocoagulation	143

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events567

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
other	Anterior Chamber Cell	Eye disorders	Focal/Grid Laser Photocoagulation	1	330
other	Anterior Chamber Cell	Eye disorders	1mg Intravitreal Triamcinolone	14	256
other	Anterior Chamber Cell	Eye disorders	4 mg Intravitreal Triamcinolone	9	254
other	Cataract	Eye disorders	Focal/Grid Laser Photocoagulation	38	330
other	Cataract	Eye disorders	1mg Intravitreal Triamcinolone	29	256
other	Cataract	Eye disorders	4 mg Intravitreal Triamcinolone	57	254
other	Cataract Cortical	Eye disorders	Focal/Grid Laser Photocoagulation	19	330
other	Cataract Cortical	Eye disorders	1mg Intravitreal Triamcinolone	22	256
other	Cataract Cortical	Eye disorders	4 mg Intravitreal Triamcinolone	32	254
other	Cataract Nuclear	Eye disorders	Focal/Grid Laser Photocoagulation	13	330

1 to 10 of 567Source ClinicalTrials.gov

See all 567 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Focal/Grid Laser Photocoagulation
Total, all-cause mortality	1mg Intravitreal Triamcinolone
Total, all-cause mortality	4 mg Intravitreal Triamcinolone
Total, other adverse events	Focal/Grid Laser Photocoagulation	69	330
Total, other adverse events	1mg Intravitreal Triamcinolone	98	256
Total, other adverse events	4 mg Intravitreal Triamcinolone	163	254
Total, serious adverse events	Focal/Grid Laser Photocoagulation	135	330
Total, serious adverse events	1mg Intravitreal Triamcinolone	69	256
Total, serious adverse events	4 mg Intravitreal Triamcinolone	54	254

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17765429	RESULT	PubMed
18662829	RESULT	PubMed
18698292	RESULT	PubMed
19273785	RESULT	PubMed
20008708	RESULT	PubMed
20122739	RESULT	PubMed
21571677	DERIVED	PubMed
33206392	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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