Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation
Status:
Completed
Trial end date:
2007-10-24
Target enrollment:
Participant gender:
Summary
This study will examine whether the drug ranibizumab is an effective treatment for macular
telangiectasia, a condition in which existing blood vessels near the macula (the back part of
the eye responsible for sharp central vision) become dilated and twisted, and new abnormal
blood vessels may form under the retina. Both the existing dilated vessels, as well the new
subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This
study will see if ranibizumab can slow or stop the leakage and growth of existing, dilated,
macular vessels in cases where new vessel formation under the retina is absent.
Patients 18 years of age and older who have macular telangiectasia without new blood vessel
formation may be eligible for this study. Visual acuity must be 20/40 or worse.
Participants receive at least four injections of ranibizumab into the eye over a 12-week
period. After the fourth injection, additional injections may be given every 4 weeks for up
to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab
treatment, patients undergo the following procedures:
- Medical history and physical examination.
- Eye examination, including dilation of the pupils and measurement of the fluid pressure
in the eye.
- Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the
blood vessels in the eyes. Photographs of the retina are taken with a special camera
that flashes a blue light into the eye. The photos show whether any dye has leaked from
the vessels into the retina.
- Indocyanine green angiography: This procedure identifies feeder vessels that may be
supplying the abnormal blood vessels. The test is similar to fluorescein angiography,
but uses a green dye and flashes an invisible light.
- Autofluorescence imaging: This test examines how well the retina functions. The back of
the eye is photographed with a bright light.
- Optical coherence tomography: This test measures retinal thickness. A light shined into
the eye produces cross-sectional pictures of the retina. The measurements are repeated
during the study to determine if retinal thickening is getting better or worse, or
staying the same.
- Stereoscopic color fundus photography: The pupils are dilated and special photographs of
the inside of the eye are taken to evaluate the retina and measure changes that occur
over time. The camera flashes a bright light into the eye for each picture.
- Follow-up visits: The doctor evaluates the effects of the study treatment before and
after each injection. Patients are contacted by phone 3 days after each injection to
check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after
the last treatment.