Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial
United States10 participantsStarted 2006-09
Plain-language summary
This research is being done to look at the effects of an experimental drug, ranibizumab, for the treatment of a condition called "idiopathic parafoveal telangiectasia" or IPT. IPT is caused by swelling in the retina (the light sensitive tissue in the back of the eye) due to leaky blood vessels in this area. Swelling in the retina can lead to blurry vision.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
β. Age \> 18 years
β. Diagnosis of bilateral IPT with macular edema documented on OCT and no evidence of choroidal neovascularization.
β. Best corrected visual acuity of better or equal to 20/200 in both eye
Exclusion criteria
β. Known hypersensitivity to humanized monoclonal antibodies
β. History (within past 6 months) 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 tachyarrhythmias requiring ongoing treatment).
β. History of stroke within 6 months of study entry.
β. Current acute ocular or periocular infection.
β. Any major surgical procedure within one month of study entry.
β. Known serious allergies to fluorescein dye.
β. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
β
What they're measuring
1
Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters