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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

Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects with Geographic Atrophy (Acucela)

  • Objective: The purpose of this study is to evaluate the safety and tolerability of the investigational drug ACU-4429 in a subset of subjects with the dry form of age-related macular degeneration.
  • Contact: Rishi P. Singh, MD, 216.445.9497, or Gail Kolin, RN, 216.445.4086

12 Week Patient Study in Neovascular Age-related Macular Degeneration (AMD)

  • Objective: This study is designed to determine whether pazopanib eye drops have the potential to reduce retinal edema and maintain or improve visual acuity in cases of previously untreated subfoveal choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) and to further characterize the safety and tolerability of pazopanib eye drops administered over a 12-week period.
  • Contact: Rishi P. Singh, MD, 216.445-9497, or Gail Kolin, RN, 216.445.4086

A One Month, Multicenter, Observational Study to Evaluate the Degree of Ocular Inflammation Associated with Pars Plana Vitrectomy (Pyramid)

  • Objective: The purpose of this study is to evaluate the degree of ocular inflammation, retinal thickening and ocular pain in subjects who are undergoing a pars plana vitrectomy.
  • Contact: Rishi P. Singh, MD, 216.445.9497, or Gail Kolin, RN, 216.445.4086

Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina (FAVOR)

  • Objective: This study will assess the safety and efficacy of Fluocinolone Acetonide Intravitreal Inserts in subjects with macular edema secondary to RVO.
  • Contact: Peter K. Kaiser, MD, 216.444.6702, or Gail Kolin, RN, 216.445.4086

Safety and Efficacy of AIN457 in Noninfectious Uveitis

  • Objective: This study will test the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.
  • Contact: Careen Lowder, MD, 216.444.3642, or Laura Holody, 216.445.2264

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

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

Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients (NAION)

  • Objective: This is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (QPI-1007) will be given to all patients who participate. This study will determine whether QPI-1007 is safe when it is injected into the eye. The study will also reveal if there are any side effects of the drug and how long it takes for the body to clear the drug.
  • Contact: Rishi P. Singh, MD, 216.445.9497, or Laura Holody, 216.445.2264

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

  • A 16 week evaluation of Novartis Health Management Tool in assessing self-test visual function in patients with AMD treated with Lucentis.
  • A Phase II Multicenter, Prospective, Randomized, Comparator Controlled, Dose Ranging Study Evaluating PF-04523655 Versus Ranibizumab in the Treatment of Subjects with Choroidal Neovascularization (MONET Study).
  • A Phase II Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration (GSK AMD).
  • Infant Aphakia Treatment Study (IATS)
  • An Open-Label, Multicenter, Phase II Trial of Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis (HUMIRA).
  • A Clinical Safety and Efficacy Comparison of NevanacĀ® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients (NEVANAC).
  • A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO).
  • 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).
  • 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)

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