A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema

NCT00369486 | Completed Phase 2 Results DMC

• 4 other identifiers: NEI-104U10EY018817-03U10EY014229-07U10EY014231-09
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study involves the enrollment of patients over 18 years of age with diabetic macular edema involving the center of the macula who have not already been given maximal laser treatment. Patients with one study eye will be randomly assigned (stratified by prior laser) with equal probability to one of five treatment groups:

1. 1.Focal laser photocoagulation (modified ETDRS technique)
2. 2.Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
3. 3.Anterior peribulbar injection of 20 mg triamcinolone
4. 4.Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser
5. 5.Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser

Conditions

Diabetic Macular Edema

Keywords

diabetic; macular; edema; peribulbar; triamcinolone; acetonide; laser; photocoagulation; intraocular; DME

Outcome Measures

Primary Outcomes (3)

• Change in Central Subfield Thickening From Baseline Through 34 Weeks

  Change in Central Subfield Thickening from Baseline measured on Optical 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. Negative changes represent a decrease in retinal thickening.

  4, 8, 17, 34 weeks

• Change in Visual Acuity Letter Score From Baseline Through 34 Weeks

  Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity.

  4, 8, 17, and 34 weeks

• Mean Visual Acuity Letter Score at Each Follow-up Visit

  Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0

  4, 8, 17, and 34 weeks

Secondary Outcomes (3)

• Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks

  17 weeks

• Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks

  4, 8, 17, 34 weeks

• Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks

  4, 8, 17, 34 weeks

Study Arms (5)

1

ACTIVE COMPARATOR

Focal laser photocoagulation (modified Early Treatment Diabetic Retinopathy Study (ETDRS) technique)

Procedure: Focal laser photocoagulation

2

EXPERIMENTAL

Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)

Drug: 40mg triamcinolone

3

EXPERIMENTAL

Anterior peribulbar injection of 20 mg triamcinolone

Drug: 20mg triamcinolone

4

EXPERIMENTAL

Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser

Drug: 40mg triamcinolone + laser

5

EXPERIMENTAL

Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser

Drug: 20mg triamcinolone + laser

Interventions

Focal laser photocoagulation PROCEDURE

Focal laser photocoagulation (modified Early Treatment Diabetic Retinopathy Study technique)

Also known as: focal/grid laser

1

40mg triamcinolone DRUG

Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)

Also known as: Kenalog

2

20mg triamcinolone DRUG

Anterior peribulbar injection of 20 mg triamcinolone

Also known as: Kenalog

3

40mg triamcinolone + laser DRUG

Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser

Also known as: Kenalog, focal/grid photocoagulation

4

20mg triamcinolone + laser DRUG

Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser

Also known as: Kenalog, focal/grid photocoagulation

5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Diagnosis of diabetes mellitus (type 1 or type 2)
• At least one eye meets the study eye criteria
• Able and willing to provide informed consent.

You may not qualify if:

• History of chronic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
• Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.
• Known allergy to any corticosteroid or any component of the delivery vehicle.
• History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week.
• History of steroid-induced intraocular pressure elevation that required IOP-lowering treatment in either eye.
• Warfarin (coumadin) currently being used.
• Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
• Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 8 months.
• Best corrected electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity score of ≥69 letters (i.e., 20/40 or better).
• Definite retinal thickening due to diabetic macular edema based on clinical exam.
• Retinal thickness in the Optical Coherence Tomography (OCT) central subfield measuring 250 microns or more.
• Maximal laser has not already been given and investigator believes that either peribulbar steroids or laser may benefit the eye (note: subjects may be enrolled without having received prior macular laser).
• Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs and OCT.
• Macular edema is considered to be due to a cause other than diabetic macular edema.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Related Publications (3)

• Chew EY, Glassman AR, Beck RW, Bressler NM, Fish GE, Ferris FL, Kinyoun JL; Diabetic Retinopathy Clinical Research Network. Ocular side effects associated with peribulbar injections of triamcinolone acetonide for diabetic macular edema. Retina. 2011 Feb;31(2):284-9. doi: 10.1097/IAE.0b013e3181f049a8.

  PMID: 20948459 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2007.02.010.

  PMID: 17544778 RESULT

• 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. doi: 10.1167/iovs.11-7321.

  PMID: 21571677 DERIVED

MeSH Terms

Conditions

Edema

Interventions

Triamcinolone; Triamcinolone Acetonide; Lasers

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Adam R. Glassman, M.S., Director
• Organization: Jaeb Center for Health Research, Diabetic Retinopathy Clinical Research Network

drcrnet@jaeb.org

(813) 975-8690

Study Officials

• Emily Chew, M.D.

  National Eye Institute (NEI)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2006
• First Posted: August 29, 2006
• Study Start: December 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: October 1, 2007
• Last Updated: August 26, 2016
• Results First Posted: June 14, 2011

Record last verified: 2016-08