Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders
Status:
Completed
Trial end date:
2007-08-15
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of a new formulation of triamcinolone
acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid
drug that decreases inflammation and scarring and is routinely used to treat eye inflammation
or swelling. The commercially available form of this drug is associated with potentially
harmful side effects thought to be due to preservatives in the preparation. This study will
use a formulation that does not contain these potentially harmful preservatives. Preliminary
findings from other studies suggest that injection of steroids in the eye can reduce retinal
thickening and improve vision. However, they may also cause mild discomfort and lead to
vision-threatening conditions. The effects of the drug on the conditions under study in this
protocol are not known.
Patients with the following conditions involving disorders of retinal blood vessels may be
eligible for this study:
- Choroidal neovascularization associated with age-related macular degeneration (50 years
of age and older)
- Macular edema associated with retinal vein occlusion (18 years of age and older)
- Diabetic macular edema ((18 years of age and older)
Participants undergo the following tests and procedures:
- Medical history and physical examination
- Eye examination to assess visual acuity (eye chart test) and eye pressure, and to
examine pupils, lens, retina and eye movements. The pupils will be dilated with drops
for this examination.
- Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected
into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina
are taken using a camera that flashes a blue light into the eye. The pictures show if
any dye has leaked from the vessels into the retina, indicating possible blood vessel
abnormality.
- Indocyanine green angiography to identify feeder vessels that may be supplying abnormal
blood vessels. This procedure is similar to fluorescein angiography, but uses a green
dye and flashes an invisible light.
- Optical coherence tomography to measure retinal thickness. This test shines a light into
the eye and produces cross-sectional pictures of the retina. These measurements are
repeated during the study to determine if retinal thickening is getting better or worse,
or staying the same.
- Stereoscopic color fundus photography to examine the back of the eye. The pupils are
dilated with eye drops to allow examination and photography of the back of the eye.
- Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic
eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide
is injected into the eye's vitreous (jelly-like substance inside the eye). After the
injection, the patient lies on his or her back for 30 minutes. An antibiotic eye
ointment is used for 2 days following treatment.
- Blood tests to measure liver and kidney function.
Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the
first treatment. Patients whose condition does not improve after 3 months do not receive any
more injections, but return for eye examinations at least once a year for 3 years. Patients
whose condition improves with treatment return for follow-up visits 6 and 9 months after the
first injection and then every 6 months for 2 more years. At each visit, a determination is
made whether another injection is needed. After each repeat injection, patients return for
follow-up visits at 1, 4, and 7 days after the injection.