Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome
Von Hippel-Lindau Syndrome
About this trial
This is an interventional treatment trial for Von Hippel-Lindau Syndrome focused on measuring Retinal Angioma, Tumor, Anti-VEGF, Monoclonal Antibody, Macular Edema, Von Hippel-Lindau Disease, VEGF, Ranibizumab, VHL
Eligibility Criteria
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.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike