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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 of science.

The Clinical Trials Department at DMEI 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 five full-time coordinators supporting ophthalmologists conducting clinical research in multiple subspecialties.

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, BA – Clinical Trials Division Manager
  • Sima Patel, BS – Clinical Trials Coordinator, IRB coordinator
  •  Iyana Freeman – Clinical Trials Coordinator
  • Alayna Lee, COA – Clinical Trials Coordinator
  • Barenca Maldonado – Clinical Trials Coordinator

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

Glaucoma

  • Study Name: Study to Evaluate the Duration of Effect of Bimatoprost SR in Open-Angle Glaucoma or Ocular Hypertension (TRITON)
  • Condition(s) under Study: Open-angle Glaucoma or Ocular Hypertension
  • Sponsor: Allergan
  • Study Summary: The objective of this randomized Phase 3b study is to evaluate the duration of intraocular pressure lowering effect and safety of up to three administrations of bimatoprost SR. Administration is accomplished via intracameral implant of a biodegradable polymer. Patients who meet enrollment criteria will be randomized to a 1:1 ratio and followed for 30 months.  This study is closed to enrollment.
  • Principal Investigator: Dr. Mahmoud Khaimi
  • Co-Investigator: Dr. Andrew Bailey
  • ClinicalTrials.gov Information: NCT03850782

Ocular Oncology

  • Study Name: Phase 2 Open-Label study of AU-011 via Suprachoroidal administration in subjects Choroidal Melanoma (AURA)
  • Condition(s) under Study: Primary indeterminate lesions and choroidal melanoma
  • Sponsor: Aura Biosciences, Inc.
  • Study Summary: To determine the safety, tolerability and preliminary efficacy AU-011 for the treatment of lesions and choroidal melanoma
  • Investigator(s): Dr. Brian Firestone
  • ClinicalTrials.gov Information: NCT04417530

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 Information: NCT04378790

Retina

  • Study Name: CONDOR

  • Sponsor: Novartis
  • Study Summary: This is a Phase III, two-arm, randomized, single-masked, multicenter study to assess the efficacy and safety of brolucizumab 6 mg compared to panretinal photocoagulation laser in patients with proliferative diabetic retinopathy. This study is closed to enrollment.

  • Principal Investigator: Dr. Vinay Shah

  • Co-Investigator: Dr. Ronald Kingsley

     

  • Study Name: Fenofibrate for Prevention of Diabetic Retinopathy Worsening (Protocol AF)
  • Conditions(s) under Study: Diabetic Retinopathy
  • Sponsor: Diabetic Retinopathy Clinical Research Network
  • Funding Source: National Institutes of Health/National Eye Institute
  • 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
  • ClinicalTrials.gov Information: NCT04661358  

 

  • Study Name: Vitreous Proteomics in Eyes with a Macular Hole (Protocol AJ)
  • Sponsor: Diabetic Retinopathy Clinical Research Network
  • Funding Source: National Institutes of Health/National Eye Institute
  • Study Summary: This is a multicenter, randomized study to verify and characterize abnormally expressed vitreous proteins in adults with macular holes. An additional objective is to create a biobank of vitreous samples from various eye disease for future use. This study is open to enrollment.
  • Principal Investigator: Dr. Vinay Shah

 

Studies Coming Soon

  • 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 starting August 2023.
  • Principal Investigator: Dr. Lea Bennett
  • Sub-Investigator: Dr. Ronald Kingsley
  • Funding Source: Department of Ophthalmology
  • ClinicalTrials.gov Information:NCT05537220
  • Study Name: Diabetic Retinopathy
  • Study Summary: Characterizing the prevalence and nature of facial recognition deficits in non-proliferative diabetic retinopathy. There will be 200 study patients in total; 100 with moderate to severe non-proliferative diabetic retinopathy, 50 with macular edema and 50 without macular edema. The third control group consists of 100 patients with normal vision, with matching the age, race, and sex to the previous control group. The study is expected to last 2 years with a possible year 3 extension.
  • Principal Investigator: Michael Wenger, PhD
  • Sub-Investigator: Dr. Vinay Shah
  • Funding Source: University of Oklahoma, Department of Psychology
  • 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 will be open to enrollment starting late fall 2023.
  • Principal Investigator: Dr. Brian Firestone
  • Funding Source: Aura Biosciences, Inc
  • IStudy Name: AU-011-401
  • Study Summary: A registry of subjects with primary indeterminate lesions or choroidal melanoma. A five year long- term follow-up study to assess long-term safety in subjects following treatment with bel-sar or alternate treatment. All subjects from AU-011-202 and AU-011-301 will transition into this study, seen on an annual basis. We have recently completed the EOS visit for our patient in AU-011-202, so we expect subject transition into the long-term follow-up within the next year.
  • Principal Investigator: Dr. Brian Firestone
  • Funding Source: Aura Biosciences, Inc.
  • Study Name: NEXPEDE-1
  • Study Summary: A randomized, multicenter, double-masked, vehicle-controlled phase 2/3 study to evaluate the safety and efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in subjects with Persistent Corneal Epithelial Defects. Subjects will be in a treatment period for up to 28 days, requiring weekly dosing. If the subject does not achieve corneal re-epithelialization at Day 29, they will receive subsequent weekly dosing for an addition 28 day period. If re-epithelialization still unachieved, they will enter open-label treatment at the discretion of the PI. Study will be open to enrollment in the fall of 2023.
  • Principal Investigator: Dr. Kamran Riaz
  • Sub-Investigator:Dr. Aman Mittal
  • Funding Source: Amber Ophthalmics, Inc.
  • ClinicalTrials.gov Identifier: NCT05966493
  • Study Name: CXL-006-A
  • Study Summary: A randomized, multicenter, double-masked, sham-controlled, parallel-group phase 3 study to evaluate the safety and efficacy of epithelium-on corneal cross-linking in patients aged 8-45 with keratoconus for 12 months. There is a 1:1 randomization ratio of intervention vs. sham, and amongst these two treatment groups, they will be stratified by age category (<21, ≥ 21) and by baseline BCVA (better than 20/40; worse than 20/40). The protocol identifies secondary objectives as assessing the effectiveness of epi-on CXL based on endpoints and time points over the study period, to evaluate the safety and tolerability of treatment, and evaluate the QOL improvements in patients getting treatment that are ≥ 21. The exploratory objectives are to evaluate the effectiveness of treatment using Scheimpflug (Pentacam) tomographic imaging. Projected to start enrollment at the end of the year.
  • Principal Investigator: Dr. Kamran Riaz
  • Sub-Investigator: Dr. Aman Mittal
  • Funding Source: Epion Therapeutics