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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
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Study Month
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0
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1
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2
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4
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8
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12
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24
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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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Fundus photos
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7F
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3F
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7F
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3F
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7F
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7F
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OCT
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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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Eye Exam 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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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 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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Fluor. Angio d
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X
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X
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Eye Exam and Fluorescein Angiography are done on the
study eye only; all other procedures are performed on both eyes.
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a =
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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.
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b =
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includes lens assessment using standard photos at 0, 4,
8, 12, 24, and 36 months.
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c =
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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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d =
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does not need to be performed if not part of usual care.
If performed at baseline, repeat at 4 months.
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