Ophthalmology Update - Cleveland Clinic

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36 OPHTHALMOLOGY UPDATE 2009 SPECIAL EDITION C L I N I C A L T R I A L S continued DIABETIC RETINOPATHY Vascular Remodeling and Effects of Angiogenic Inhibition in Diabetic Retinopathy (NIH) Objective: This study will test whether the pattern of the retinal vasculature changes in patients with different levels of diabetic retinopathy can be quantified using computerized image analysis. In addition, the study will evaluate whether new drugs to treat diabetic retinopathy will be able to reverse these vascular changes. Contact: Peter K. Kaiser, MD, 216.444.6702 or Ly Pung, RN, 216.445.6497 UVEITIS A Prospective, Multicenter, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients with Non-Infectious Acute Anterior Segment Uveitis (EYEGATE) Objective: The purpose of this Phase II study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate ® II Drug Delivery System in patients with non-infectious acute anterior segment uveitis. Contact: Careen Lowder, MD, PhD, 216.444.3642 or Ly Pung, RN, 216.445.6497 An Open-Label, Multicenter, Phase II Trial of Adalimumab (Humira ® ) in the Treatment of Refractory Non-infectious Uveitis (HUMIRA) Objective: This study will assess the safety and efficacy of adalimumab, a humanized monoclonal antibody, against TNF-α (Abbott) in the treatment of refractory, vision-threatening, non-infectious uveitis. Contact: Careen Lowder, MD, PhD, 216.444.3642 or Laura Holody, 216.445.2264 PEDIATRIC EYE DISEASE Infant Aphakia Treatment Study (IATS) Objective: The primary purpose of this study is to determine whether infants with a unilateral congenital cataract are more likely to develop better vision following cataract extraction surgery if they undergo primary implantation of an intraocular lens or if they are treated primarily with a contact lens. In addition, the study will compare the occurrence of postoperative complications and the degree of parental stress between the two treatments. Contact: Elias Traboulsi, MD, 216.444.4363 or Sue Crowe, RN, 216.445.3840
GENETICS Studies of the Molecular Genetics of Eye Diseases (BRTT) Objective: The objective of this project is to study the molecular genetics of ophthalmic disorders through the compilation of a collection of DNA, plasma and eye tissue samples from patients and from families with a broad range of eye diseases and malformations. Contact: Elias Traboulsi, MD, 216.444.4363 or Patrice Nerone, RN, 216.445.9886 CORNEA /REFRACTIVE SURGERY A Clinical Safety and Efficacy Comparison of Nevanac ® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients (NEVANAC) Objective: The purpose of this study is to determine whether Nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients. Contact: Richard Gans, MD, 216.444.0848 or Gail Kolin, RN, 216.445.4086 CLEVELAND CLINIC | COLE EYE INSTITUTE | CLEVELANDCLINIC.ORG/OUSPECIAL | RESEARCH IN FOLLOWUP The following studies have completed patient enrollment in the last year at Cole Eye Institute and are in follow up: • A 24-month Randomized, Double-masked, Controlled, Multicenter, Phase IIIB study Assessing Safety and Efficacy of Verteporfin (Visudyne ® ) Photodynamic Therapy Administered in Conjunction with Ranibizumab (Lucentis ® ) versus Ranibizumab (Lucentis ® ) Monotherapy in Patients with Subfoveal Choroidal Neovascularization Secondary to Agerelated Macular Degeneration (DENALI) • A Phase III, Multicenter, Randomized, Sham-Controlled Study of the Efficacy and Safety of Ranibizumab Compared with Sham in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO) • A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects with Clinically Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus (DME) • An 8-Week, Multicenter, Masked, Randomized Trial to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System Compared with Sham DEX PS DDS Applicator System in the Treatment of Non-Infectious Ocular Inflammation of the Posterior Segment in Patients with Intermediate Uveitis (POSURDEX UVEITIS) • Posterior Lamellar Endothelial Keratoplasty Study (PLEK) • US Clinical Study of the ACRYSOF Angle-Supported Phakic IOL • A 2-year, Multicenter, Randomized, Controlled, Masked, Dose-finding Trial to Assess the Safety and Efficacy of Multiple Intravitreal Injections of AGN 211745 in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (SIRIUS) 37
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