Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome
Status:
Completed
Trial end date:
2007-08-15
Target enrollment:
Participant gender:
Summary
This study will examine whether he drug ranibizumab can slow or stop the growth of angiomas
(blood vessel tumors) in patients with Von Hippel-Lindau syndrome (VHL). Angiomas commonly
develop in the back of the eye on the retina and the optic nerve in patients with VHL.
Although these tumors are not cancerous, they may cause significant vision loss. Current
treatments, including laser therapy, cryotherapy, and vitrectomy, may not be successful or
possible for all patients. Ranibizumab decreases production of VEGF, a growth factor that is
important for the formation of new blood vessels and that is elevated in patients with VHL.
Preliminary findings from other studies suggest that ranibizumab can reduce retinal
thickening caused by vessel and tumor growth and improve vision.
Patients 18 years of age and older with retinal angiomas due to VHL in one or both eyes and
central vision loss of 20/40 or worse may be eligible for this study. Participants undergo
the following tests and procedures:
- Medical history, physical examination, electrocardiogram (EKG) and blood tests.
- Eye examination, including eye pressure measurement and dilation of the pupils to
examine the retina.
- Fluorescein angiography to evaluate the eye's blood vessels. For this test, 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.
- Optical coherence tomography to measure retinal thickness. The eyes are examined through
a machine that produces cross-sectional pictures of the retina. These measures are
repeated during the study to determine changes, if any, in retinal thickening.
- Stereoscopic color fundus photography to examine the back of the eye. The pupils are
dilated with eye drops to examine and photograph the back of the eye.
- Electroretinogram (ERG) to measure electrical responses generated from within the
retina. For this test, the patient sits in a dark room for 30 minutes with his or her
eyes patched. Then, a small silver disk electrode is taped to the forehead, 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 an open 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.
- Ranibizumab injections to treat ocular angiomas. Ranibizumab is injected through a
needle into the eye's vitreous (gel-like substance that fills the inside of the eye).
Seven injections are given over a 28-week period. Before each injection, the surface of
the eye is numbed with anesthetic eye drops. This is followed by injection of another
anesthetic into the lower portion of the eye in the clear tissue surrounding the white
of the eye. After a few minutes, the ranibizumab is injected into the vitreous. Patients
receive ranibizumab injections at the first visit (during enrollment) and again at 4, 8,
12, 16, 20 and 24 weeks after the first injection. At the 28-week visit, the doctor will
determine if further treatment is needed. Patients can continue to have injections every
4 weeks until 1 year of follow-up (54 weeks).
At each injection visit, participants repeat most of the tests described above to evaluate
the response to treatment and return a week later for another eye examination.