Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089765
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-08-12
Brief Title:
Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Intravitreal Injection of Ranibizumab rhuFAB V2 for Advanced Ocular Disease of Von Hippel-Lindau VHL Disease
Status:
COMPLETED
Status Verified Date:
2007-08-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 2040 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 eyes 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 eyes 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
Patients 18 years of age and older with retinal angiomas due to VHL in one or both eyes and central vision loss of 2040 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 eyes 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 eyes 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
Detailed Description:
Von Hippel-Lindau Syndrome VHL is an autosomal dominant heritable disorder in which multiple benign and malignant neoplasms and cysts of specific histopathologies develop in the kidney adrenal gland pancreas brain spinal cord eye inner ear epididymis and broad ligament Retinal angioma may be one of the earliest manifestations of VHL disease and may lead to a significant decrease in visual acuity of the affected individual These tumors rarely regress spontaneously The main cause of vision loss is retinal edema specifically macular edema secondary to enlargement of peripheral retinal angiomas or angiomas found on or around the optic disk Treatment of retinal angiomas depends on the location and size of the lesions but typically consists of photocoagulation or cryotherapy However there is no proven effective therapy for the treatment of VHL ocular lesions on or surrounding the optic nerve or lesions in the peripheral retina too large to respond to the traditional therapies The genetic mutation found in VHL disease up-regulates the production of vascular endothelial growth factor VEGF Immunochemical studies of the VHL ocular lesions as well as others found elsewhere in the body show marked increase in VEGF This open-label study will pilot the use of an anti-VEGF therapy ranibizumab rhuFab V2 in 5 participants to investigate the potential efficacy as a treatment for retinal angiomas associated with VHL Participants will receive 7 intravitreal injections of study drug over a 6 month period with the option of up to seven additional injections at the same dose and schedule during follow-up for a maximum period of 1 year after the initiation of treatment The primary outcome will be a change in the best corrected visual acuity of 15 letters or more eight weeks after a participant receives the final study injection The secondary outcomes will be a reduction in retinal thickening and leakage eight weeks after the participants receives the final study injection and adverse events including local and systemic toxicities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-EI-0240 | None | None | None |