Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation
Status:
Completed
Trial end date:
2006-10-30
Target enrollment:
Participant gender:
Summary
This study will compare the side effects of two treatments for diabetic macular edema, in
which blood vessels in the retina (tissue that lines the back of the eye) become leaky and
the retina and macula (the center part of the retina that is responsible for fine vision)
swell, causing vision loss.
Patients 18 years of age and older with diabetes mellitus and macular edema in one or both
eyes may be eligible for this study. Candidates are screened with the following tests and
procedures:
- Blood pressure measurement.
- Blood tests to measure HbA1c, a measure of the patient's diabetes control.
- Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens,
retina and eye movements. The pupils are dilated with drops for this examination.
- Eye photography to help evaluate the status of the retina and changes that may occur in
the future. Photographs of the inside of the eye are taken using a camera that flashes a
bright light into the eye.
- Electroretinograms (ERG) to measure electrical responses generated in the retina.
Wearing eye patches, the patient sits in a dark room for 30 minutes. Then, electrodes
are taped to the forehead and an earlobe. The eye patches are removed, the surface of
the eye is numbed with eye drops, and contact lenses are placed on the eyes. The patient
looks inside a white globe that emits a series of light flashes for about 20 minutes.
The contact lenses sense small electrical signals generated by the retina when the light
flashes.
- Optical coherence tomography to measure retinal thickness. The eye is examined with a
machine that produces cross-sectional pictures of the retina. These measurements are
repeated during the study to determine whether retinal thickening is improving,
worsening, or staying the same.
Patients with macular edema in both eyes receive laser therapy in one eye and triamcinolone
injections in the other. Patients with just one affected eye are randomly assigned to receive
either laser or triamcinolone treatment. Those who receive only laser therapy may later
receive triamcinolone injections in the second eye if it, too, develops macular edema.
For the laser treatment, the eye surface is numbed with drops and a contact lens is placed on
the eye during the laser beam application. Before the treatment, patients may have
fluorescein angiography, in which pictures of the retina are taken using a yellow dye. The
dye is injected into a vein and travels to the blood vessels in the eye. The camera flashes a
blue light in the eye and takes pictures that show the amount of dye leakage into the retina.
This helps guide the laser treatment. Patients return for follow-up visits every 4 months for
3 years. If the macular edema is gone, no additional treatment is given and patients are
followed as often as every 2 months. If the edema does return, additional treatments may be
done at subsequent visits. Patients whose vision worsens considerably at the end of 1 year
may be treated with a steroid injection, unless the other eye has also been treated with
triamcinolone.
For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the
pupil, and possibly and anesthetic injection, are put in the eye before the medicine is
injected into the vitreous (jelly-like substance inside the eye). Then, the patient lies on
his or her back for 30 minutes before being discharged home. Patients return for follow-up
visits 4 days and 4 weeks after the injection, and then every 4 months for 3 years. Patients
whose edema resolves are followed as often as every 2 months. Those whose edema returns have
additional injections at the 4-month visits. Patients whose condition does not improve after
1 year or whose vision worsens may undergo laser treatment.