Status:
COMPLETED
Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Von Hippel-Lindau Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ba...
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 glan...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant must understand and sign the informed consent.
- Participant must be at least 18 years of age.
- Participant must have retinal angiomas secondary to VHL in one or both eyes.
- Participant must have either optic nerve tumors or peripheral tumors that have caused central vision loss of 20/40 or worse.
- Participant must have clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography.
- All women of childbearing potential must have a negative urine pregnancy test at baseline, and be willing to undergo urine pregnancy testing immediately prior to each injection, and monthly for at least 2 months following the last dose of ranibizumab.
- Women of child-bearing potential who are sexually active and men who are sexually active are required to use two forms of birth control during the course of the study.
- EXCLUSION CRITERIA:
- History (within past 5 years) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment).
- History of stroke within 12 months of study entry.
- History within the past five years of a chronic ocular or periocular infection (including any history of ocular herpes zoster).
- Current acute ocular or periocular infection.
- Any major surgical procedure within one month of study entry.
- Known serious allergies to fluorescein dye.
- Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc).
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
- History of vitrectomy surgery in the study eye.
- History of glaucoma filtering surgery in the study eye.
- History of corneal transplant in the study eye.
Exclusion
Key Trial Info
Start Date :
August 10 2004
Trial Type :
INTERVENTIONAL
End Date :
August 15 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00089765
Start Date
August 10 2004
End Date
August 15 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892