Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site

Protocol: A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
Status: Closed
Start Date: 07/01/2004
End Date: 10/03/2008
Clinical Trial ID: NCT00367133
Public Dataset:  Download

 

A Randomized Trial Comparing

Intravitreal Triamcinolone Acetonide and

Laser Photocoagulation for

Diabetic Macular Edema

Protocol Status: Completed

"Click here to view protocol"

A. Study Design

  • Randomized, multi-center clinical trial.

B. Objectives

1.  To determine whether intravitreal triamcinolone acetonide injections at doses of 1mg or 4mg produce greater benefit, with an acceptable safety profile, than macular laser photocoagulation in the treatment of diabetic macular edema.

2.  To compare the efficacy and safety of the 1mg and 4mg triamcinolone acetonide doses.

C. Major Eligibility Criteria

  • Age >=18 years.
  • Study eye with best corrected E-ETDRS acuity >24 letters (20/320 or better) and <73 letters (worse than 20/40).
  • Study eye with center-involved DME present on clinical exam and on OCT.
  • Mean retinal thickness on two OCT measurements >250 microns in the central subfield.
  • Fellow eye either eligible or has acuity >19 letters (20/400 or better) and has not been previously treated with intravitreal corticosteroids.


D. Treatment Groups

  • Patients with one study eye will be randomly assigned to one of the three treatment groups:

1.  Laser photocoagulation.

2.  1mg intravitreal triamcinolone acetonide injection

3.  4mg intravitreal triamcinolone acetonide injection

 

  • For patients with two study eyes, the right eye will be randomly assigned to one of the three treatment groups above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4mg) will be randomly assigned to the left eye.

E. Duration of Follow-Up: Three years.

F. Main Efficacy Outcomes
Primary: >=15-letter improvement in visual acuity from baseline to 3 years

Secondary: Change in retinal thickening (measured on OCT)

G. Main Safety Outcomes
(1) Elevated Intraocular pressure/glaucoma, (2) cataract/cataract surgery, (3) endophthalmitis (bacterial or inflammatory), (4) retinal detachment.

H. Timing of Outcome Assessments
Primary outcome at 3 years (preliminary outcome assessment at 1 year).

I. Sample Size: 689 patients or 813 eyes.

J. Schedule of Study Visits and Examination Procedures
Follow-up visits are divided into those that are considered outcome assessment visits and those that are considered part of the treatment regimes.

Outcome Assessment Visits
The schedule below includes the standardized visits conducted for all patients in all three treatment groups. Testing at these visits is conducted on both eyes, unless otherwise indicated.

 

Study Month

 

0

4

8*

12

16*

20*

24

28*

32*

36

E-ETDRS visual acuity a

X

X

X

X

X

X

X

X

X

X

Fundus photos

7F

3F

 

7F

 

 

7F

 

 

7F

OCT b

X

X

X

X

X

X

X

X

X

X

IOP

X

X

X

X

X

X

X

X

X

X

Eye Exam c

X

X

X

X

X

X

X

X

X

X

Blood Pressure

X

 

 

X

 

 

X

 

 

X

HbA1c d

X

 

 

X

 

 

X

 

 

X

Fluor. Angio e

X

 

 

 

 

 

 

 

 

 

PK Blood Draws f

X

X

 

 

 

 

 

 

 

 

 

Testing is on both eyes at each visit unless otherwise specified below.

a =

includes protocol refraction at 0, 4, 12, 24, 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 =

performed on both eyes at 0 (performed twice), 4, 12, 24, and 36 months and on the study eye only at other visits.

c =

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

d =

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)

e =

does not need to be performed if not part of usual care.

f =

only at selected sites for patients randomized to either of the triamcinolone acetonide treatment groups.

* visit window may be extended if necessary for visit to occur no sooner than 3.5 months from the last treatment

 

In the intravitreal triamcinolone acetonide groups, standard of care post-treatment visits occur 4 weeks after each intravitreal injection. Data collected at these visits will be analyzed under the assumption that none of the recorded adverse events would have occurred in the absense of the treatment.

In the laser photocoagulation group, a treatment session may be given in multiple sittings, necessitating additional visits.

 


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