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Clinical Trials

Clinical trials are an essential step in the careful and controlled evaluation of new diagnostic tests and treatments. They typically examine both safety and effectiveness. The Dean McGee Eye Institute (DMEI) and its faculty and staff believe that our cutting-edge involvement in such studies is critical to our mission and to society. Without these trials, physicians are unable to derive the data that
ultimately foster the best in patient care. They also offer patients who enroll the most modern cutting-edge care under intensive scrutiny and close observation. Patients choose to participate in clinical trials for many reasons: they may have the opportunity to receive treatments with tremendous promise but which are unavailable outside of a trial, while some simply appreciate the
intrinsic feeling of contributing to the advancement ofscience.

The Clinical Trials Department atDMEI has a wide range of studies, mostly funded by grants from the National Eye Institute/National Institutes of Health (NEI/NIH) and the pharmaceutical industry. There are currently two full-time coordinators supporting ophthalmologists conducting clinical research in multiple subspecialties.

In addition to the multitude of faculty studies that the clinical trials department supports, the department collaborates with our OU partners by providing eye examinations for approximately 30 research studies throughout the campus.

We hope that you will read further to learn more about our studies. We invite you to contact the coordinator or principal investigator if you have a patient who might qualify for one of the studies listed below.

Clinical Trials Staff

  • Crystal McAfee, COT, MA – Clinical Trials Division Manager
  • Bethia Feldman – Clinical Trials Coordinator
  • Allison Garber, COA – Clinical Trials Coordinator
  • Asia Jackson – Clinical Trials Coordinator

Additional information for all studies can be found on www.clinicaltrials.gov.

 

Ocular Oncology

  • Study Name: AU-011-301
  • Study Summary: A Phase III, masked, controlled trial to evaluate the efficacy and safety of belzupacap sarotalocan (AU-011) treatment compared to sham control in subjects with primary indeterminate lesions or small choroidal melanoma. Secondary objectives is to assess the systemic pharmacokinetics and immunogenicity of bel-sar at varying dosages (80µg, 40µg, or sham) with suprachoroidal administration. This study is open to enrollment.
  • Principal Investigator: Dr. Brian Firestone
  • Funding Source: Aura Biosciences, Inc.
  • ClinicalTrials.gov Identifier: NCT06007690

Pediatric Ophthalmology

  • Study Name: Sequential vs Simultaneous Spectacles plus Patching for Amblyopia (ATS22)
  • Sponsor: Pediatric Eye Disease Investigator Group
  • Study Summary: This is a randomized, multicenter trial to compare the efficacy of sequential versus simultaneous spectacles plus patching for patients with amblyopia. The primary objective is to determine whether simultaneous treatment with spectacles and patching has an equivalent visual acuity (VA) outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to <7 years of age and 7 to <13 years of age. There is a 1:1 randomization ration for each age cohort. The patients are followed for 56 weeks. This study is open to enrollment.
  • Principal Investigator: Dr. Maria Lim
  • Co-Investigator(s): Dr. R. Michael Siatkowski and Dr. Tammy Yanovitch
  • Funding Source: National Institutes of Health/National Eye Institute
  • ClinicalTrials.gov Identifier: NCT04378790

Cornea

  • Study Name: Aurion Cell Therapy Procedure
  • Sponsor: Aurion Biotech, Inc.
  • Study Summary: Study explores the injection of cultured cells with a ROCK inhibitor for the treatment of corneal endothelial cell disorders, such as Fuch’s endothelial corneal dystrophy. The primary objective is to increase the CEC density. According to research already performed overseas, finding confirmed the safety and efficacy of cultured hCEC intection therapy for up to 5 years after the surgery. Closed to enrollment.
  • Principal Investigator: Dr. Kamran Riaz
  • ClinicalTrials.gov Identifier: NCT06041256

Retina

  • Study Name: Fenofibrate for Prevention of Diabetic Retinopathy Worsening (Protocol AF)
  • Conditions(s) under Study: Diabetic Retinopathy
  • Study Summary: This is a multicenter, randomized trial to evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 4 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR). This study is open to enrollment.
  • Principal Investigator: Dr. Ronald Kingsley
  • Sub-Investigator: Dr. Jila Noori
  • Sponsor: Diabetic Retinopathy Clinical Research Network
  • Funding Source: National Institutes of Health/National Eye Institute
  • ClinicalTrials.gov Identifier:  NCT04661358

 

  • Study Name: Oral N-acetylcysteine for Retinitis Pigmentosa (NAC Attack)
  • Study Summary: This is a Phase III multicenter, randomized, parallel, double masked, placebo-controlled study evaluating the efficacy and safety of oral N-Acetylcysteine in patient with Retinitis Pigmentosa. There is a 2:1 randomization ration of intervention vs. placebo and patients are followed for 45 months. The rationale for this study is to test the efficacy of oral NAC on the cone survival and function in patients with RP. This study is open to enrollment.
  • Principal Investigator: Dr. Lea Bennett
  • Sub-Investigator: Dr. Ronald Kingsley
  • Sponsor: Johns Hopkins University
  • Funding Source: National Institutes of Health/National Eye Institute
  • ClinicalTrials.gov Identifier: NCT05537220