Currently Recruiting
The following studies are either currently enrolling new patients or are pending approval by the Institutional Review Board and should be enrolling shortly:
Age-Related Macular Degeneration
- A Phase I open-label, dose escalation trial of REDD14NP delivered by a single intravitreal injection to patients with choroidal neovascularization secondary to exudative Age-related Macular Degeneration. (QUARK)
Objective: This is an open-label, dose escalation study in which patents will receive a single intravitreal injection of REDD14NP. The primary objective of the study is to determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection.
Contact: Peter K. Kaiser, M.D. 216.444.6702 or Lynn Bartko, R.N. 216.444.7137
- A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects with Neovascular Age-Related Macular Degeneration (VEGF Trap)
Objective: This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration.
Contact: Peter K. Kaiser, M.D. 216.444.6702 or Laura Holody 216.445.2264
Retinal Vein Occlusion
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An Open Label, Multi-Center Extension Study To Evaluate the Safety and Tolerability of Ranibizumab in Subjects with Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech Sponsored Ranibizumab Study (HORIZON 2)
Objective: This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in subjects with macular edema secondary to RVO who have completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g or FVF4166g).
Contact: Rishi P. Singh, M.D. (216) 445-9497 or Gail Kolin, R.N. (216) 445-4086
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, M.D. (216) 444-6702 or Ly Pung, R.N. (216) 445-6497
Uveitis
- A Prospective, Multi-Center, 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, M.D. (216) 444-3642 or Ly Pung, R.N. (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, M.D. (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, M.D. (216) 444-4363 or Sue Crowe, R.N. (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, M.D. (216) 444-4363 or Patrice Nerone, R.N. (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, M.D. (216) 444-0848 or Gail Kolin, R.N. (216) 445-4086
- Pending: Donor Preparation Pressure and Refractive Shift in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Objective: The purpose of the study is to determine if the infusion pressure used during DSAEK (Descemet-stripping automated endothelial keratoplasty) donor tissue preparation affects postoperative graft morphology, refractive outcome, and graft endothelial cell count in the recipient.
Contact: William J. Dupps, M.D., Ph.D. (216) 444-8396 or Ly Pung, R.N. (216) 445-6497
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 age-related 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, Multi-Center, 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)
