A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Diabetic Macular Edema
Interventions:	Procedure: Focal laser photocoagulation Drug: 40mg triamcinolone Drug: 20mg triamcinolone Drug: 40mg triamcinolone + laser Drug: 20mg triamcinolone + laser

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty-two clinical sites across the United States recruited 129 eyes of 109 subjects between December 2004 and September 2005. 113 subjects were randomized, but 4 were not included in any of the analysis because they were ineligible.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Focal Laser Photocoagulation	Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
Posterior Peribulbar Injection of 40 mg Triamcinolone	Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Anterior Peribulbar Injection of 20 mg Triamcinolone	Anterior peribulbar injection of 20 mg triamcinolone
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser	Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser	Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month

Participant Flow for 4 periods

Period 1: 4-Week Visit

	Focal Laser Photocoagulation	Posterior Peribulbar Injection of 40 mg Triamcinolone	Anterior Peribulbar Injection of 20 mg Triamcinolone	Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser	Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
STARTED	38 ^[1]	21 ^[1]	23 ^[1]	22 ^[1]	25 ^[1]
COMPLETED	36 ^[1]	19 ^[2]	22 ^[1]	20 ^[1]	24 ^[1]
NOT COMPLETED	2	2	1	2	1
Missed visit	2	2	0	2	1
Dropped	0	0	1	0	0

[1]	Number of eyes
[2]	Number of eyes;

Period 2: 8-Week Visit

	Focal Laser Photocoagulation	Posterior Peribulbar Injection of 40 mg Triamcinolone	Anterior Peribulbar Injection of 20 mg Triamcinolone	Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser	Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
STARTED	38 ^[1]	21 ^[1]	22 ^[1]	22 ^[1]	25 ^[1]
COMPLETED	38 ^[1]	20 ^[1]	22 ^[1]	21 ^[1]	24 ^[1]
NOT COMPLETED	0	1	0	1	1
Missed visit	0	1	0	0	1
Dropped	0	0	0	1	0

[1]	Number of eyes

Period 3: 17-Week Visit

	Focal Laser Photocoagulation	Posterior Peribulbar Injection of 40 mg Triamcinolone	Anterior Peribulbar Injection of 20 mg Triamcinolone	Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser	Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
STARTED	38 ^[1]	21 ^[1]	23 ^[1]	22 ^[1]	25 ^[1]
COMPLETED	38 ^[1]	21 ^[1]	22 ^[1]	21 ^[1]	24 ^[1]
NOT COMPLETED	0	0	1	1	1
Missed visit	0	0	1	1	1

[1]	Number of eyes

Period 4: 34-Week Visit

	Focal Laser Photocoagulation	Posterior Peribulbar Injection of 40 mg Triamcinolone	Anterior Peribulbar Injection of 20 mg Triamcinolone	Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser	Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
STARTED	38 ^[1]	21 ^[1]	23 ^[1]	22 ^[1]	25 ^[2]
COMPLETED	38 ^[1]	20 ^[1]	22 ^[1]	19 ^[1]	22 ^[1]
NOT COMPLETED	0	1	1	3	3
Dropped	0	1	1	3	3

[1]	Number of eyes
[2]	Number of eyes that

Baseline Characteristics

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Reporting Groups

	Description
Focal Laser Photocoagulation	Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
Posterior Peribulbar Injection of 40 mg Triamcinolone	Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Anterior Peribulbar Injection of 20 mg Triamcinolone	Anterior peribulbar injection of 20 mg triamcinolone
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser	Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser	Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month

Baseline Measures

	Focal Laser Photocoagulation	Posterior Peribulbar Injection of 40 mg Triamcinolone	Anterior Peribulbar Injection of 20 mg Triamcinolone	Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser	Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser	Total
Number of Participants [units: participants]	38	21	23	22	25	129
Age [units: years] Mean ± Standard Deviation	58 ± 11	58 ± 12	60 ± 8	64 ± 7	63 ± 13	60 ± 11
Gender [units: participants]
Female	17	13	5	4	8	47
Male	21	8	18	18	17	82
Race/Ethnicity, Customized [units: participants]
White	31	16	21	19	19	106
African-American	3	3	0	3	4	13
Hispanic or Latino	1	1	2	0	1	5
Asian	3	1	0	0	0	4
Other	0	0	0	0	1	1
Cystoid Abnormality on Ocular Coherence Tomography (OCT) [units: eyes]
Yes	30	17	20	18	19	104
No	8	4	3	4	6	25
Diabetes Type [units: Participants]
Type 1	3	3	3	0	1	10
Type 2	35	18	20	22	24	119
Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity ^[1] [units: eyes]
>=79: 20/25 or better	25	12	17	10	11	75
78-69: 20/32-20/40	13	9	6	12	14	54
Received Prior Focal Photocoagulation [units: eyes]
No	21	7	8	10	11	57
Yes	17	14	15	12	14	72
Received Prior Scatter (Panretinal) Photocoagulation [units: eyes]
No	34	16	19	21	25	115
Yes	4	5	4	1	0	14
Subretinal Fluid on Ocular Coherence Tomography (OCT) ^[2] [units: eyes]
Yes	4	1	0	1	2	8
No	34	20	23	21	23	121
Central Subfield Thickness ^[3] [units: microns] Mean ± Standard Deviation	324 ± 70	321 ± 53	342 ± 79	319 ± 59	336 ± 58	328 ± 65
Duration of Diabetes ^[4] [units: years] Mean ± Standard Deviation	14 ± 10	14 ± 9	15 ± 7	16 ± 7	15 ± 9	15 ± 9
Hemoglobin A1c [units: percentage] Mean ± Standard Deviation	7.9 ± 1.7	7.3 ± 1.6	8.1 ± 1.7	7.8 ± 1.3	7.5 ± 1.8	7.8 ± 1.6
Intraocular Pressure (mm Hg) ^[4] [units: mm Hg] Mean ± Standard Deviation	16 ± 3	16 ± 4	16 ± 4	16 ± 3	17 ± 3	16 ± 3
Mean visual acuity letter score ^[5] [units: letter score] Mean ± Standard Deviation	80 ± 5	79 ± 4	81 ± 5	79 ± 7	78 ± 6	79 ± 5
Total Retinal Volume (mm^3) [units: mm^3] Mean ± Standard Deviation	8.2 ± 1.2	7.6 ± 0.9	8.1 ± 1.2	7.8 ± 0.6	7.9 ± 0.8	8.0 ± 1.0

[1]	Best corrected visual acuity letter score as measured by a certified tester using an electronic early treatment diabetic retinopathy study (e-ETDRS) method and approximate Snellen equivalent. Best value on the scale is 97, worst value 0.
[2]	Ocular Coherence Tomography (OCT) images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.
[3]	Measured by Ocular Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.
[4]	N=129 eyes
[5]	Baseline Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) Visual Acuity Letter Score: best value = 97; letter score worst value = 0

Outcome Measures

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1. Primary:

Change in Central Subfield Thickening From Baseline Through 34 Weeks [ Time Frame: 4, 8, 17, 34 weeks ]

Show Outcome Measure 1

2. Primary:

Change in Visual Acuity Letter Score From Baseline Through 34 Weeks [ Time Frame: 4, 8, 17, and 34 weeks ]

Show Outcome Measure 2

3. Primary:

Mean Visual Acuity Letter Score at Each Follow-up Visit [ Time Frame: 4, 8, 17, and 34 weeks ]

Show Outcome Measure 3

4. Secondary:

Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks [ Time Frame: 17 weeks ]

Show Outcome Measure 4

5. Secondary:

Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks [ Time Frame: 4, 8, 17, 34 weeks ]

Show Outcome Measure 5

6. Secondary:

Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks [ Time Frame: 4, 8, 17, 34 weeks ]

Show Outcome Measure 6

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Adam R. Glassman, M.S., Director
Organization: Jaeb Center for Health Research, Diabetic Retinopathy Clinical Research Network
phone: (813) 975-8690
e-mail: drcrnet@jaeb.org

Publications of Results:

Diabetic Retinopathy Clinical Research Network; Chew E, Strauber S, Beck R, Aiello LP, Antoszyk A, Bressler N, Browning D, Danis R, Fan J, Flaxel C, Friedman S, Glassman A, Kollman C, Lazarus H. Randomized trial of peribulbar triamcinolone acetonide with and without focal photocoagulation for mild diabetic macular edema: a pilot study. Ophthalmology. 2007 Jun;114(6):1190-6.

Publications automatically indexed to this study:

Gangaputra S, Almukhtar T, Glassman AR, Aiello LP, Bressler N, Bressler SB, Danis RP, Davis MD; Diabetic Retinopathy Clinical Research Network. Comparison of film and digital fundus photographs in eyes of individuals with diabetes mellitus. Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6168-73. Print 2011 Aug.

Responsible Party:	Roy W. Beck, M.D., Ph.D., Director, Jaeb Center for Health Research (DRCR.net)
ClinicalTrials.gov Identifier:	NCT00369486 History of Changes
Other Study ID Numbers:	NEI-104, U10EY018817-03, U10EY014229-07, U10EY014231-09
Study First Received:	August 25, 2006
Results First Received:	October 14, 2009
Last Updated:	May 12, 2011
Health Authority:	United States: Food and Drug Administration