Current Ophthalmology Clinical Trials

The following studies are either currently enrolling patients or are pending approval and should be enrolling shortly:

Retinal Diseases

A Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 Versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration

Objective: Comparing the efficacy and safety of RTH258 versus aflibercept in subjects with neovascular age-related macular degeneration with respect to the change in best-corrected visual acuity (BCVA) from baseline to Week 48.

Contact: Rishi Singh, MD, 216.445.9497, or Dionne Chandler, MHA, 216.444.3762

A Multicenter, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared with Eylea® for the Treatment of Recurrent Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Objective: Comparing the efficacy and safety over 108 weeks of a single intravitreal implantation of the NT-503-3 ECT vs. Eylea (aflibercept) injected intravitreally every 8 weeks in patients with recurrent subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) who have been previously treated with anti-VEGF injections.

Contact: Rishi Singh, MD, 216.445.9497, or Diana McOwen, BSN, RN, 216.445.2264

A Phase II, Multicenter, Randomized Active Treatment- Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients with Subfoveal Neovascular Age-Related Macular Degeneration

Objective: Evaluate the relative efficacy of 10-mg/mL, 40-mg/mL and 100-mg/mL formulations of ranibizumab, delivered via the implant, as measured by the time a patient first requires implant refill according to protocol-defined refill criteria.

Contact: Rishi Singh, MD, 216.445.9497, or Dionne Chandler, MHA, 216.444.3735

A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients Geographic Atrophy (GA) — FILLY

Objective: To demonstrate superiority of monthly and every-other-month APL-2 IVT injections compared with sham injections based on the mean change in GA lesion size as measured by FAF and the number and severity of treatment-emergent adverse events.

Contact: Rishi Singh, MD, 216.445.9497, or Amber Bourcier, MPH, 216.445.7176

Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection (IAI) Treatment for Retinal Edema (PERMEATE Study)

Objective: Evaluate the retinal vascular dynamics associated with IAI therapy in eyes with diabetic macular edema or macular edema secondary to retinal vein occlusion.

Contact: Justis Ehlers, MD, 216.636.0183, or Laura Stiegel, 216.636.0183

Prospective Intraoperative and Perioperative Ophthalmic Imaging with Optical Coherence Tomography (PIONEER Study)

Objective: Assess the feasibility and utility of intraoperative OCT and perioperative OCT in optimizing the management of surgical ophthalmic diseases.

Contact: Justis Ehlers, MD, 216.636.0183, or Jamie Reese, RN, 216.636.0183

Ozurdex for Diabetic Macular Edema Treated with Pars Plana Vitrectomy and Membrane Removal (OPERA Study)

Objective: Examine the use of Ozurdex® (dexamethasone intravitreal implant) in patients who are undergoing pars plana vitrectomy for macular edema due to diabetic macular edema.

Contact: Sunil Srivastava, MD, 216.636.2286, or Kim Baynes, 216.444.2566

Uveitis

A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension, in the Treatment of Subjects with Macular Edema Following Uveitis

Objective: This study is to evaluate the safety, tolerability and efficacy of CLS-TA in patients with macular edema following noninfectious uveitis.

Contact: Sunil Srivastava, MD, 216.636.2286, or Kim Baynes, 216.444.2566

Automated Analysis of Anterior Chamber Inflammation by Optical Coherence Tomography

Objective: A prospective, observational, case series investigating the feasibility of utilizing optical coherence tomography (OCT) scans of inflammation in the anterior chamber, vitreous and sclera of patients with uveitis.

Contact: Sunil Srivastava, MD, 216.636.2286, or Kim Baynes, 216.444.2566

Pediatric Eye Disease

Binocular Computer Activities for Treatment of Amblyopia (ATS18)

Objective: To compare the effectiveness of 1 hour/day binocular game play with 2 hours/day patching in children 5-17 years old.

Contact: Fatema Ghasia, MD, 216.444.4363, or Diana McOwen, BSN, RN, 216.445.3762

Genetics

Molecular Genetics of Eye Diseases

Objective: Study the molecular ophthalmic disorders through the compilation of a collection of DNA, plasma and eye tissue samples from patients and families with a broad range of eye diseases and malformations.

Contact: Elias Traboulsi, MD, 216.444.4363, or Meghan Marino, 216.445.7671

Genetics in Uveitis

Objective: Identify changes in genes that may lead to uveitis.

Contact: Sunil Srivastava, MD, 216.636.2286, or Meghan Marino, 216.444.2566