Fluocinolone Implant to Treat Macular Degeneration
Status:
Completed
Trial end date:
2001-12-01
Target enrollment:
Participant gender:
Summary
This study will test the safety and effectiveness of a fluocinolone implant to treat
age-related macular degeneration. This eye disease can severely impair central vision,
affecting a person's ability to read, drive, and carry out daily activities. It is the
leading cause of vision loss in people over age 60. The fluocinolone implant is a tiny
plastic rod with a pellet of the steroid fluocinolone on the end. The pellet slowly dissolves
and releases the medication into the fluid in the eye.
Vision loss in macular degeneration is caused by the formation of new blood vessels in the
choroid-a thin, pigmented vascular layer of the eye behind the retina. These abnormal vessels
leak blood under the macula, the part of the retina that determines central vision. Tissue
studies show evidence of inflammation in the retinas of patients. This study will test
whether the slow release of the steroid fluocinolone directly into the affected part of the
eye can prevent or slow further vision loss. Preliminary animal and human studies with
fluocinolone implants have shown some benefit in reducing blood vessel growth and improving
or stabilizing vision.
Patients 50 years of age and older with age-related macular degeneration may be eligible for
this study. Study patients will be randomly assigned to one of two treatment groups. One will
receive a 0.5-mg dose implant; the other will receive a 2-mg dose implant. Theoretically, the
implants can release the medicine for 2 to 3 years.
Participants will have a medical history, physical examination and complete eye examination.
The latter will include a vision test, eye pressure measurement, examination of the pupils,
lens, retina, and eye movements. Photographs of the eye will be taken with a special camera.
Patients will also undergo fluorescein angiography, a test that takes pictures of the retina
using a yellow dye called sodium fluorescein. The dye is injected into the blood stream
through a vein. After it reaches the blood vessels of the eye, photographs are taken of the
retina.
When the above tests are completed, patients will be scheduled for surgery to place the
implant. The procedure will be done under either local or general anesthesia. Follow-up
visits will be scheduled 1, 2, 4, and 6 weeks after surgery, then at 3 and 6 months after
surgery, and then every 6 months until the implant is depleted of medicine or is removed.
Several of the exams described above will be repeated during the follow-up period to evaluate
the treatment and side effects, if any.