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A Randomized Trial Comparing
Intravitreal Triamcinolone
Acetonide and
Laser Photocoagulation for
Diabetic Macular Edema
Protocol
Status: Enrollment 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.
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Study Month
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0
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4
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8*
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12
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16*
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20*
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24
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28*
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32*
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36
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E-ETDRS visual acuity a
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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Fundus photos
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7F
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3F
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7F
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7F
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7F
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OCT b
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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IOP
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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Eye Exam c
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X
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X
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X
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X
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X
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X
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X
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X
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X
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X
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Blood Pressure
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X
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X
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X
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X
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HbA1c d
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X
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X
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X
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X
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Fluor. Angio e
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X
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PK Blood Draws f
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X
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X
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Testing is on both eyes at each visit unless otherwise
specified below.
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a =
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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.
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b =
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performed on both eyes at 0 (performed twice), 4, 12,
24, and 36 months and on the study eye only at other visits.
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c =
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includes lens assessment using standard photos at 0, 4,
12, 24, and 36 months
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d =
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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)
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e =
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does not need to be performed if not part of usual care.
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f =
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only at selected sites for patients randomized to either
of the triamcinolone acetonide treatment groups.
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* visit window may be extended if necessary for visit to
occur no sooner than 3.5 months from the last treatment
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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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