Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site

Protocol: A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema
Status: Closed
Start Date: 08/31/2004
End Date: 11/01/2007
Clinical Trial ID: NCT00369486
Public Dataset:  Download

 

A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema

Protocol Status: Completed

"Click here to view protocol"

A. Study Design

  • Phase 2 randomized, multi-center clinical trial.

B. Objectives

1.  To estimate the incidence of improvement of DME following a posterior peribulbar 40 mg triamcinolone acetonide injection compared with laser.

2.  To estimate the incidence of improvement of DME following an anterior peribulbar 20 mg triamcinolone acetonide injection compared with laser.

3.  To estimate the incidence of intraocular pressure elevation and other complications with each type of injection.

4.  To provide preliminary data comparing the incidence of improvement of DME with a peribulbar triamcinolone alone versus peribulbar triamcinolone followed by laser photocoagulation.

C. Major Eligibility Criteria

  • Age >=18 years.
  • At least one eye meeting the following criteria:
    • Best corrected E-ETDRS acuity >= 69 letters.
    • Retinal thickening due to DME based on clinical exam and a thickness of 250 microns or more in the central subfield on OCT.
    • Maximal laser, defined as the investigator believing that additional laser treatment will provide the patient an opportunity for an improvement in visual acuity, has not already been given and investigator believes that either peribulbar steroids or laser may benefit the eye.

D. Treatment Groups
100 patients will be randomized. A minimum of 40 eyes will be randomized that have not received prior laser (or other treatment) for DME.

Patients with One Study Eye will be randomized with equal probability to one of five treatment groups:

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

Patients with Two Study Eyes
One eye randomly assigned to laser and the other eye randomly assigned to one of the four triamcinolone groups.

E. Duration of follow-up: Three years.

F. Main Efficacy Outcomes
Primary

  • Visual acuity (measured with E-ETDRS).

Secondary

  • Retinal thickening measured on OCT.
  • Persistence/recurrence of DME either retreated or meeting criteria for retreatment during the first 8 months.
  • Change in area of retinal thickening and in threat to/involvement of the center of macula (estimated in color photographs).

G. Main Safety Outcomes

  • Intraocular pressure elevation/glaucoma.
  • Cataract.
  • Ptosis.
  • Complications of injection procedure.

H. Schedule of Study Visits and Examination Procedures

 

Study Month

 

0

1

2

4

8

12

24

36

E-ETDRS visual acuity a

X

X

X

X

X

X

X

X

Fundus photos

7F

 

 

3F

7F

3F

7F

7F

OCT

X

X

X

X

X

X

X

X

IOP

X

X

X

X

X

X

X

X

Eye Exam b

X

X

X

X

X

X

X

X

Blood Pressure

X

 

 

 

 

X

X

X

HbA1c c

X

 

 

X

X

X

X

X

Fluor. Angio d

X

 

 

X

 

 

 

 

 

Eye Exam and Fluorescein Angiography are done on the study eye only; all other procedures are performed on both eyes.

a =

includes protocol refraction at 0, 8 months, 24 months, and 36 months. E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.

b =

includes lens assessment using standard photos at 0, 4, 8, 12, 24, and 36 months.

c =

does not need to be repeated if HbA1c and lab normal values are available from within the prior 3 months (at baseline, can be performed within 3 weeks after randomization).

d =

does not need to be performed if not part of usual care. If performed at baseline, repeat at 4 months.

 


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