Telangiectasia Clinical Trial
Official title:
Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia With Neovascularization
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 new vessels forming
under the retina.
Patients 18 years of age and older who have macular telangiectasia in both eyes and new blood
vessel formation under the retina in at least one eye 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.
Retinal telangiectasis is a group of rare, idiopathic retinal vascular anomalies affecting
the retinal capillaries in which irregular capillary dilation and incompetence occur in the
macula. This is the former group 2 in the Gass classification of idiopathic juxtafoveal
telangiectasia in which fluorescein angiography showed leakage with capillary dilation. These
patients typically are diagnosed in their fifth or sixth decade of life. Both sexes may be
affected. Minimal exudation, superficial retinal crystalline deposits, and right-angle
venules characterize this disorder. As the disease progresses, intraretinal pigment plaques
and eventually subretinal/choroidal neovascularization develop. Currently, these patients
will be classified as macular telangiectasia. The pathogenesis of the disease is unknown.
Because of the leakage of the retinal vessels and also the finding of neovascularization, it
is possible that vascular endothelial growth factor (VEGF) may be implicated in this disease.
The purpose of this study is to evaluate the possible role of ranibizumab for the treatment
of five participants with macular telangiectasia with hyperfluorescence on fluorescein
angiography, with vision decreased to 20/40 or worse, with neovascularization. The primary
outcome will be a visual acuity change, either increase or decrease of 15 letters or more at
one year. The secondary outcomes measured at one year will include visual acuity changes of
10 letters or more, the change in retinal thickening documented by OCT, the extent and degree
of fluorescein leakage, the change in area of hypofluorescence, and the change in central
retinal sensitivity. This is a pilot study designed to evaluate the feasibility and potential
efficacy of treating patients with macular telangiectasia in a larger, phase III study within
the organization of the MAC TEL Research Group, sponsored by the Lowy Foundation. Currently,
the research group is enrolling 200 patients affected with this condition for a natural
history study in 22 international clinical centers.
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