Clinical Research
We are setting the standard for ophthalmic care in West Virginia and beyond.
We are dedicated to pioneering the future of eye health and vision care through relentless innovation and cutting-edge research.
Clinical trials play a growing role in the medical options patients have. Nearly 4,000 experimental drug therapies are in active clinical trials today, and that number will continue to grow as improvements are made in detecting disease, in understanding the root causes of acute and chronic illnesses, and in discovering medical innovations.
Clinical Trials
Clinical trials help to establish therapeutic innovations for vision-threatening diseases. By participating with informed consent in clinical trials at the WVU Eye Institute, patients can receive new treatments before they become widely available to the public. In addition, because certain vision-threatening diseases, such as glaucoma, tend to run in families, participating in clinical trials may one day benefit the future generations of participants.
To find out if you are eligible to participate in a clinical trial, contact Athena Echols at [email protected].
CLINICAL TRIALS
Clarifying the Optimal Application of SLT Therapy Trial (COAST)
Primary Investigator: Anthony Realini, MD, MPH
Disease entity studied: Glaucoma and Ocular Hypertension
Summary: Using SLT therapy to lower IOP in patients with POAG or Ocular hypertension
Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (ButterflEYE)
Primary Investigator: Ghassan Ghorayeb, MD
Disease entity: Retinopathy of Prematurity
Summary: (ButterflEYE) study (NCT04101721) was a completed Phase 3 clinical trial evaluating the use of aflibercept (Eylea) for Retinopathy of Prematurity (ROP) in infants. The clinical trial is now complete, and the FDA has since approved Eylea for this condition based on its results.
A Study Investigating Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Adult Participants with Geographic Atrophy (SIENNA)
Primary Investigator: Ghassan Ghorayeb, MD
Disease entity: Age-related Macular Degeneration (AMD) and for those specially with geographic atrophy
Summary: Phase 3 randomized, double masked, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Pozelimab in combination with Cemdisiran or Cemdisiran alone in participants with geographic atrophy secondary to age-related macular degeneration
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants with Neovascular Age-Related Macular Degeneration (ARTEMIS)
Primary Investigator: Ghassan Ghorayeb, MD
Disease Entity: Neovascular Age-Related Macular Degeneration (nAMD)
Summary: A Multi-Center, Randomized, Double-Masked, Active-Comparator-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene soroparvovec (Ixo-vec) in Participants with Neovascular Age-Related Macular Degeneration (ARTEMIS)
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared with Placebo in Male and Female Adult Participants with Moderate-to-severe active Thyroid Eye Disease (Horizon)
Primary Investigator: John Nguyen, MD
Disease Entity: Thyroid Eye Disease (TED)
Summary: Phase 3 randomized, double masked, placebo-controlled, parallel-group, trial to evaluate the efficacy, safety and tolerability or subcutaneous Teprotumumab in participants with moderate to serve active thyroid eye disease
Note: WVU eye institute was the first site to enroll a participant for the trial
Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease (Immunovant 3202)
Primary Investigator: John Nguyen, MD
Disease Entity: Thyroid Eye Disease (TED)
Summary: Phase 3 randomized, quadruple masked, placebo-controlled study of batoclimab for the treatment of participants with active thyroid eye disease
Extension Study to Assess Batoclimab in Participants with Thyroid Eye Disease (Immunovant 3203)
Primary Investigator: John Nguyen, MD
Primary Investigator: Dr. Nguyen
Disease Entity: Thyroid Eye Disease (TED)
Treatment Arms: First treatment arm will be an observational cohort in which participants will enter a 24 week non-treatment observational study during which the durability of their proptosis response will be assessed. The second are is the treatment cohort comprised of participants classified as proptosis nonresponses who will enter an open-label, non-placebo-controlled study of batoclimab as an initial or extended treatment of batoclimab of 680mg for 12 weeks followed by 340 mg for 12 weeks.
Number of Pts enrolled: 2
Summary: 2-cohort extension study for eligible participants completing the Week 24 visit on the feeder studies, IMVT-1401-3201 or IMVT-1401-3202. Participants will be assessed as proptosis responders or non-responders at Week 24 in the feeder studies
Sponsor: Immunovant Sciences GmbH
Drug Company: Immunovant Sciences GmbH
A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age with Thyroid Eye Disease (spiriTED) (Tourmaline)
Primary Investigator: John Nguyen, MD
Disease Entity: Thyroid Eye Disease (TED)
Summary: Phase 2b randomized, double masked, placebo-controlled dose ranging study of TOUR006 in participants with thyroid eye disease
Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease (REVEAL-1)
Primary Investigator: John Nguyen, MD
Disease Entity: Thyroid Eye Disease (TED)
Summary: A phase 3, randomized, double-masked, placebo-controlled, efficacy, safety, and tolerability study of VRDN-003 in participants with active thyroid eye disease (TED)
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED) (REVEAL-2)
Primary Investigator: John Nguyen, MD
Disease Entity: Thyroid Eye Disease (TED)
Summary: A phase 3, randomized, double-masked, placebo-controlled, efficacy, safety, and tolerability study of VRDN-003 in participants with chronic thyroid eye disease (TED)
A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age with Thyroid Eye Disease (spiriTED)
Primary Investigator: John Nguyen, MD and Joel Palko, MD, in collaboration with FBI
Summary: The goal of this proposal is to curate high quality iris images of patients with ocular diseases or injuries using a variety of ocular biometry devices utilized at the WVU Eye Institute. A prospective dataset with inclusion of iris images obtained with a commercially available near infrared camera will be created with enrollment of patients interested in sharing data when receiving care at WVU. Images will be taken pre and post-intervention for common ocular procedures including but not limited to cataract surgery, glaucoma surgery, corneal transplants, eye medications administration and laser peripheral iridotomy. We expect to provide researchers with a large dataset of longitudinal iris images in patients with common as well as uncommon ocular conditions.
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED) (REVEAL-2)
Primary Investigator: John Nguyen, MD and Joel Palko, MD, in collaboration with FBI
Summary: to curate a large volume of high-quality iris images of patients before and after manipulations that alter their MRD and pupil size. These images will be used to determine the influence of pupil dilation and MRD separately and in combination on iris registration using Hamming distance.
Genetic Testing
Primary Investigator: Monique Leys MD, EBO
Disease Entity: Retinal diseases
Summary: Using genetic testing services such as Invitae and My Retina Tracker to look for potential genes of interest
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease (UplighTED)
Primary Investigator: John Nguyen, MD
Disease Entity: Thyroid Eye Disease (TED)
Summary: A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease
Kerecis Real-World Fish Skin Graft Registry (ISACOD)
Kerecis Real World Fish Skin Graft Registry “ISACOD”
Primary Investigator: John Nguyen, MD
Summary: Kerecis devices intended to be used for the management of wounds including reinforcement of soft tissue where weakness exists, in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery
A Study of AMG 732 in Healthy Participants and Participants with Thyroid Eye Disease
Primary Investigator: John Nguyen, MD
Disease Entity: Thyroid Eye Disease (TED)
Summary: This is a phase 1/2, randomized, double-masked, placebo-controlled,
multicenter study to assess the safety, PK, and efficacy of AMG 732 in healthy subjects and subjects with moderate-to-severe active TED.
Efficacy of adjunctive topical losartan following Ahmed Glaucoma Valve Surgery.
Sponsor – American Glaucoma Society
12/1/2023 – 9/1/2026
Research
We are dedicated to pioneering the future of eye health and vision care through relentless innovation and cutting-edge research.
The WVU Eye Institute clinical research program is directed by Tony Realini, MD, MPH.
Learn more about clinical research opportunities.
RESEARCH
Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients with Diabetic Macular Edema
Dr. Ghassan Ghorayeb – GR40349
My Retina Track Genetic Testing Protocol
Dr. Monique Leys – My Retina Tracker Registry
Phase II Trial of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects
Dr. Lingo Lai – Phase II Trial of ST266 Eye Drops
Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Every 4 Weeks Versus Aflibercept every 4 Weeks in Adult Patients with Visual Impairment Due to Diabetic Macular Edema
Dr. Ghassan Ghorayeb – CRTH258B2305
Phase IIIb Study Assessing the Efficacy and Safety Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-Control Regimen in Patients with Neovascular Age-Related Macular Degeneration
Dr. Ghassan Ghorayeb – CRTH258A2303
Study of Disease Progression in Genetically-Defined Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneration
Dr. Ghassan Ghorayeb – GTSCOPE
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients with Retinopathy of Prematurity
Dr. Ghassan Ghorayeb – VGFTe-ROP-1920
Research Faculty
Ghassan Ghorayeb, MD
Lingo Lai, MD
Brian McMillan, MD
John Nguyen, MD
Kevin Halenda, MD