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  Research Center >> Clinical Trials

Clinical Trials

CURRENTLY RECRUITING

The following studies are currently enrolling. All studies have been approved by the Institutional Review Board.

Genetics

Studies of the Molecular Genetics of Eye Diseases

Objective: To map the genes for inherited eye diseases. To screen candidate genes for mutations in a variety of genetic ocular disorders, including ocular malformations, congenital cataracts and retinal dystrophies.

Contact: E. Traboulsi, M.D., at (216) 444-4363 or S. Crowe, C.O.T., at (216) 445-3840

The Genetics of Strabismus

Objective: To discover the genes that cause some strabismus syndromes, including those for accommodative esotropia, congenital esotropia, congenital ocular fibrosis syndrome, intermittent exotropia, Brown syndrome and Duane syndrome.

Contact: E. Traboulsi, M.D., at (216) 444-4363 or S. Crowe, C.O.T., at (216) 445-3840

Pediatrics

Amblyopia Treatment Study (ATS5): A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old

Objective:  The Amblyopia Treatment Study is a two-part study.  The first part is being conducted to determine whether wearing glasses can improve amblyopia.  The second part is being conducted to determine whether patching treatment improves amblyopia.  Two hours of patching the sound eye combined with at least one hour of near work will be compared with a control group which will wear glasses only.  The study is funded by the National Eye Institute and is coordinated by the JAEB center for Health Research, a nonprofit clinical research center.  The Pediatric Eye Investigator Group includes pediatric optometrists and pediatric ophthalmologists.

Contact: D. Tucker, O.D., or A. Marcotty, M.D., at (216) 831-0120 or L. Slaby, C.O.A., at (330) 963-4843

Infant Aphakia Treatment Study

Objective:  To determine whether infants with a unilateral congenital cataract are more likely to develop better vision following cataract extraction surgery if (1) they undergo the primary implantation of an IOL or if (2) they are treated primarily with a contact lens. 

Contact: E. Traboulsi, M.D., at (216) 444-4363 or S. Crowe, C.O.T., at (216) 445-3840

Refractive Surgery

Vision Therapy: A Progressive Controlled Study on the Effectiveness of Vision Therapy in Eliminating Asthenopia in a Symptomatic Population

Eligibility Criteria: Patients who are 18 to 35 years of age and have any of the following symptoms: eye strain, occasional blurred vision when using a computer or performing other near work, occasional headaches, have words run together or fall asleep when doing prolonged computer work or near work. If eligible, participation will involve approximately three visual assessments at the Cleveland Clinic Division of Ophthalmology at Beachwood and required equipment for therapy. Compensation of $100 will be allotted for travel expenses.

Contact: D. Tucker, O.D., at (216) 831-0120 or L. Slaby, C.O.A., at (330) 963-4843

ACRYSOF Angle-Supported Phakic Intraocular Lens

Objective:  To collect information on the safety and effectiveness of the artificial lens ACRYSOF for the correction of severe myopia.  This study lens will be implanted behind the cornea in the anterior chamber.  The lens is made of a soft acrylic material that allows the lens to be folded for implantation and therefore can be inserted through a smaller incision than other rigid lens designs.  Participation in this study will last about 3 years.

Contact: R. Krueger, M.D., at (216) 445-8585 or R. Scott at (216) 444-0680

Retinal Diseases

A Phase III, Multi-center, Randomized, Double-masked, Active Treatment -Controlled Study of the Efficacy and Safety of RHUFAB V2 (Ranibizumab) Compared with Verteporfin (Visudyne) Photodynamic Therapy in Subjects with Predominantly Classic Subfoveal Neovascular Age-related Macular Degeneration

Objective: To evaluate the efficacy of intravitreal injections of ranibizumab administered monthly compared with verteporfin PDT in preventing vision loss, as measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 12 months compared with baseline.

Contact: P. Kaiser, M.D., at (216) 444-6702 or L. Holody, C.O.A., at (216) 445-3762

Protocol B7A-MC-MBDL Reduction in the Occurrence of Center-Threatening Diabetic Macular Edema

Objective: The primary objective of this study is to test the hypothesis that oral administration of 32 mg per day of Ruboxistaurin for approximately 36 months will reduce, relative to placebo, the occurrence of center-threatening diabetic macular edema as assessed by fundus photography in patients with non-clinically significant macular edema and nonproliferative diabetic retinopathy at baseline.

Contact: P. Kaiser, M.D., at (216) 444-6702 or C. Rosal, R.N., B.S.N., at (216) 445-1256

A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, to Determine the Safety, Efficacy and Pharmacokinetics of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients with Recent Vision Loss Due to Macular Edema Secondary to CRVO

Objective:  To determine the effectiveness of pegaptanib sodium in improving vision in patients with CRVO.  Injections or sham will be every 6 weeks with one week post-injection checks throughout the study.  The study will last one year.  Patients must have been diagnosed with CRVO within the last 6 months.

Contact: H. Lewis, M.D., at (216) 444-0430 or L. Schaaf, R.N., at (216) 445-4086

An Evaluation of Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) versus Sham Administration in Patients at Risk for Developing Sight-Threatening Choroidal Neovascularization Due to Exudative Age‑Related Macular Degeneration (AMD) AART

Objective: To evaluate the effectiveness of anecortave acetate in stopping the progression of the “dry” or early form of AMD to the “wet” or advanced form.  Depot administration or sham (like an injection) will be every six months for four years for a total of nine visits.  Patients must have “wet” AMD in one eye and “dry” AMD in the other.  Vision in the “dry” eye must be equivalent to 20/40 or better.

Contact: P. Kaiser, M.D., at (216) 444-6702 or L. Schaaf, R.N., at (216) 445-4086

The Standard Care versus Corticosteroid for Retinal Vein Occlusion Study

Objective:  To evaluate the effectiveness of triamcinolone acetonide injections for treatment of macular edema versus standard treatment.  Patients will have 11 to 13 visits over a period of up to three years.

Contact: P. Kaiser, M.D., at (216) 444-6702 or L. Holody, C.O.A., at (216) 445-3762

A Six-Month Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial (with Six-Month Open-Label Extension) to Assess the Safety and Efficacy of 700 μg and 350 μg Dexamethasone Posterior Segment Drug Delivery System

Objective:  To evaluate the safety and efficacy of the 700 μg DEX PS DDS Applicator System and 350 μg DEX PS DDS Applicator System compared with a Sham DEX PS DDS Applicator System (needle-less applicator) for six months in patients with macular edema following branch retinal vein occlusion or central retinal vein occlusion.  The safety of the 700 μg DEX PS DDS Applicator System will be assessed for an additional 6 months in patients who qualify for treatment in an open-label safety extension.

Contact:  P. Kaiser, M.D., at (216) 444-6702 or L. Schaaf, R.N., at (216) 445-4086

Glaucoma

Advanced Imaging for Glaucoma

Objective: Advanced Imaging for Glaucoma (AIG) is a multi-center bioengineering partnership sponsored by the National Eye Institute. This partnership includes four clinical centers: the Cleveland Clinic Foundation (CCF), University of Pittsburgh Medical Center/University of Pittsburgh School of Medicine (UPMC), the University of Miami (Bascom Palmer Eye Institute) and the University of Southern California. The goal of the partnership is to develop advanced imaging technologies to improve the detection and management of glaucoma. The advanced imagining technologies include optical coherence tomography, scanning laser polarimetry and scanning laser tomography. The technologies will be evaluated in a longitudinal five-year clinical trial composed of glaucoma suspects, glaucoma patients and normal subjects.

Contact: S. Smith, M.D., M.P.H., at (216) 444-4821 or R. Scott (216) 444-0680