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Clinical Trials

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:

Retinal Diseases

Ozurdex for diabetic macular Edema treated with Pars plana vitrectomy and membrane Removal (OPERA study)

  • Contact: Sunil Srivastava, MD (216.636.2286), Kim Baynes (216.444.2566)

Investigator Initiated Interventional Study of Subjects With Diabetic Macular Edema Treated With Intravitreal Aflibercept Injection Previously Treated With Other Anti-VEGF Agents. (SWAPTWO)

  • Contact: Rishi Singh, MD (216.445.9497), Diana McOwen, RN (216.445.3762)

Prevention of Macular Edema in Patients with Diabetic Retinopathy Undergoing Cataract Surgery

  • Contact: Rishi Singh, MD (216.445.9497), Diana McOwen, RN (216.445.3762)

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

  • Contact: Justis Ehlers, MD (216.445.2226), Jamie Reese, RN (216.445.9886), Laura Stiegel (216.636.0183)

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

  • Contact: Rishi Singh, MD (216.445.9497), Amber Sours (216.445.7176)

A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess The Efficacy And Safety of Lampalizumab Administered Intravitreaaly To Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration

  • Contact: Rishi Singh, MD (216.445.9497), Dionne Chandler (216.444.3735)

A Randomized, Double Masked, Placebo Controlled Study Evaluating ORACEA® in Subjects with Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration

  • Contact: Rishi Singh, MD (216.445.9497), Amber Sours (216.445.7176)

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

  • Contact: Rishi Singh, MD (216.445.9497), Amber Sours (216.445.7176)

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 (LADDER)

  • Contact: Aleksandra Rachitskaya, MD (216.445.9519), Dionne Chandler (216.444.3735)

A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Double – Masked, Parallel Group, 28-Week Study To Investigate The Safety, Tolerability, Pharmacokinetics, And Efficacy of RO6867461 Administered Intravitreally In Patients With Diabetic Macular Edema

  • Contact: Rishi Singh, MD (216.445.9497), Pamela Moorehead (216.445.5248)
Uveitis

A Controlled, Multi-Center Study of the Utilization and Safety of the MK II Inserter and the safety of the FAI Insert in Subjects with Non-infectious Uveitis Affecting the Posterior Segment of the Eye

  • Contact: Sunil Srivastava, MD (216.636.2286), Kim Baynes (216.444.2566)
Genetics

Studies of the Molecular Genetics of Eye Diseases

  • 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 Sonal Uppal, PhD, 216.444.7137
Glaucoma

Comparing the Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma

  • Objective: The purpose of this study is to compare standard treatment strategies for glaucoma, including therapeutics, laser and other types of surgery.
  • Contact: Edward Rockwood, MD, 216.444.1995, or Gail Kolin, RN, 216.445.4086
Pediatric Eye Disease

Bilateral Lateral Rectus Recession versus Unilateral Recess-Resect for Intermittent Exotropia (IXT1)

  • Objective: The purpose of this study is to evaluate the effectiveness of bilateral lateral rectus muscle recession versus unilateral lateral rectus recession with medial rectus resection procedures for the treatment of strabismus.
  • Contact: Elias Traboulsi, MD, 216.444.4363, or Sue Crowe, RN, 216.445.3840

Increasing Patching for Amblyopia in Children 3 to < 8 Years Old (ATS15)

  • Objective: This study is designed to evaluate the effectiveness of increasing prescribed patching treatment after visual acuity has stabilized with initial treatment and amblyopia is still present.
  • Contact: Elias Traboulsi, MD, 216.444.4363, or Sue Crowe, RN, 216.445.3840
Cornea and Refractive Surgery

Donor Preparation Pressure and Refractive Shift in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

  • Objective: The purpose of the study is to determine if the infusion pressure used during DSAEK (Descemet's-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, MD, PhD, 216.444.8396, or Laura Holody, 216.445.2264
Other

A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single Or Multi-Dose Intravitreal Injection(s) To Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

  • Contact: Gregory Kosmorsky, DO (216.444.2855), Amber Sours (216.445.7176)

Study of Adult Strabismus: A Prospective Observational Study of Adult Strabismus (SAS1)

  • Contact: Elias Traboulsi, MD (216.444.4363), Diana McOwen, RN (216.445.3762)

The studies below have completed patient enrollment in the last year at Cole Eye Institute and are in follow-up:

  • Pediatric Cataract Surgery Outcomes Registry (CO2) (Elias Traboulsi, MD)
  • Glasses versus Observation for Moderate Hypermetropia in Young Children (Elias Traboulsi, MD)
  • A Phase-3 Randomized Double-masked Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista (anti-PDGF-B Pegylated Aptamer) Administered in Combination with Lucentis Compared to Lucentis Monotherapy in Subjects with Subfoveal Neovascular Age Related Macular Degeneration (Rishi Singh, MD)
  • The Infant Aphakia Treatment Study (Elias Traboulsi, MD)
  • Intermittent Exotropia Study 1; A Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia, Extension (Elias Traboulsi, MD)
  • Long Term Safety Follow-up for Subjects Previously Implanted with the AcrySof® CachetT Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57” (William J. Dupps, MD)

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