Clinical Eye Research Unit

The Clinical Eye Research Unit (CERU) at the University of Wisconsin has been conducting research with human subjects for over 40 years. CERU is an academic research organization that enhances ophthalmic care and develops methods to prevent and treat blindness, we excel in clinical trials, translational research and research education services, as well as through multi-disciplinary collaborations.

UW–Madison Department of Ophthalmology and Visual Sciences (DOVS) has been, and continues to be, at the forefront of vision research. The Clinical Eye Research Unit (CERU) is inextricably linked to this success, providing DOVS researchers with accurate, reliable results from the clinical trials it administers.

Clinical trials in vision research sponsored by the National Eye Institute (NEI) a division of the National Institutes of Health (NIH) have led to new medications, supplements and methods for disease detection that have saved or improved the eyesight of millions of people. The CERU has been involved with many of these clinical trials including but not limited to AREDS, AREDS 2, SCORE, SCORE 2, DRCRnet trials, Pedig pediatric trials, CAPT, and CATT. Many of these trials were able to reveal important data in discovering safe and effective treatments for eye diseases and vision loss.

TRIAL INDICATIONS

  • Diabetic macular edema
  • Albinism
  • Glaucoma
  • Diabetic retinopathy
  • Cataract
  • Thyroid eye disease
  • Dry eyes
  • Eye inflammation
  • Contact lens
  • Macular telangiectasia
  • Geographic atrophy
  • Age-related macular degeneration
  • Uveitis
  • Intermittent exotropia
  • Retinal vein occlusion
  • Zoster eye disease
  • Amblyopia
  • Conjunctivitis
  • Inherited genetic eye disorders

The Clinical Eye Research Unit within the Department of Ophthalmology and Visual Sciences is a leading resource for investigator-initiated clinical research projects, clinical trials, education of future generations of clinical researchers, and serves as the liaison for interdisciplinary collaborations with other departments at the University of Wisconsin-Madison.

 

— Dr. Mihai Mititelu, Associate Professor, Medical Director of Clinical Eye Research Unit

While CERU serves as the clinical research team for DOVS, our mandate allows for collaboration on any study where medications given for a patient’s initial indication can affect the eye. Because of this, CERU is frequently involved in clinical trials initiated by departments within the UW–Madison School of Medicine and Public Health, as well as schools throughout the UW–Madison campus. This campus-wide academic research model, along with our relationship with UW Hospital and Carbone Cancer Center, has resulted in CERU’s involvement in collaborative projects that extend beyond the scope of DOVS.

CERU is a self-sufficient unit that can provide its own imaging and diagnostics for most ophthalmology trial needs. CERU has years of experience coordinating trials for Phase I, II, III, and IV studies. A very strong tradition of involvement in clinical trials exists, whether it be smaller local investigator-initiated trials or playing a major role in large nationwide studies.

The CERU team collaborates with doctors, staff, campus partners, and research sponsors to foresee the needs of those living with ophthalmic diseases. We strive to provide sight-saving prevention and treatment solutions.

Our staff are Certified Clinical Research Coordinators with the Association of Clinical Research Professionals. Our areas of expertise include, but are not limited to, technical assessments and direct patient care, patient education and advocacy, data collection and management, and regulatory compliance.

Indisputably, our most important role is to guide patients through the treatment of their difficult eye condition, offering them not only the most current medical techniques and treatments, but also compassionate and knowledgeable care committed to protecting their safety.

 

— Jennie Perry-Raymond, Clinical Trials Administrator

Clinical Eye Research Unit Team

Active Clinical Trials

Mihai Mititelu

Associate Professor, Medical Director of the Clinical Eye Research Unit

Active Clinical Trials
Active Clinical Trials

Jennie R. Perry-Raymond

Clinical Trials Administrator

608-265-4659

Active Clinical Trials
Active Clinical Trials

Angie M. Adler

Study Coordinator and Regulatory Specialist

608-265-7557

Active Clinical Trials
Active Clinical Trials

Bonnie Verges

Research Technician and Photographer

Active Clinical Trials
Active Clinical Trials

Kristine A. Dietzman

Study Coordinator

Active Clinical Trials
Active Clinical Trials

Christopher M. Smith

Study Coordinator and Photographer

Active Clinical Trials
Active Clinical Trials

Nickie J. Stangel

Study Coordinator

Active Clinical Trials

Clinical Trials

A Multicenter, Randomized, Double-Masked, Controlled Study to Assess the Efficacy and Safety of Ons-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Aug 28 2019 // Sponsor: Outlook Therapeutics, Inc Principal Investigator: Mihai Mititelu, MD, MPH Study Coordinator: Nickie Stangel  Study Objective: This study will assess the efficacy and safety of ONS-5010 (an ophthalmic-specific bevacizumab) 1.25 mg intravitreal injections administered monthly… Read More

A Multicenter, Randomized, Double-Masked, Controlled Study to Assess the Efficacy and Safety of Ons-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (RAVEN)

Jun 12 2019 // Sponsor: Novartis Pharmaceuticals Principal Investigator: Michael Altaweel, MD Study Coordinator: Angie Adler Study Objective: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema… Read More

An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (RAVEN)

An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (RAPTOR)

Jun 12 2019 // Sponsor: Novartis Pharmaceuticals Principal Investigator: Michael Altaweel, MD Study Coordinator: Angie Adler Study Objective: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema… Read More

An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (RAPTOR)

A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KINGFISHER)

Jun 12 2019 // Sponsor: Novartis Pharmaceuticals Principal Investigator: Michael Altaweel, MD Study Coordinator: Angie Adler Study Objective: The purpose of this study is to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients… Read More

A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KINGFISHER)

A Two-year, Three-arm, Randomized, Double-masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema (KESTREL)

Jun 12 2019 // Sponsor: Novartis Pharmaceuticals Principal Investigator: Michael Altaweel, MD Study Coordinator: Angie Adler Study Objective: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment… Read More

A Two-year, Three-arm, Randomized, Double-masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema (KESTREL)

A Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRx in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

Jun 12 2019 // Sponsor: Ionis Pharmaceuticals, Inc. Principal Investigator: Kim Stepien, MD Study Coordinator: Kris Dietzman Study Objective: The purpose of the study is to evaluate the effect of IONIS-FB-LRx on the rate of change of the area… Read More

A Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRx in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration APL2-303 DERBY

Jun 12 2019 // Sponsor: Apellis Pharmaceuticals, Inc. Principal Investigator: Mihai Mititelu, MD Study Coordinator: Chris Smith Study Objective: This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple… Read More

Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration APL2-303 DERBY

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves’ Ophthalmopathy (GO)

Jun 12 2019 // Sponsor: Immunovant Sciences GmbH Principal Investigator: Mark Lucarelli, MD Study Coordinator: Angie Adler Study Objective: The purpose of this study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 (administered subcutaneously)… Read More

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves’ Ophthalmopathy (GO)

A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)

Jun 12 2019 // Sponsor: Genentech, Inc. Principal Investigator: Barb Blodi, MD Study Coordinator: Kris Dietzman Study Objective: This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of RO7171009 administered every 4 weeks (Q4W) or every… Read More

A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)

A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia (CHAMP)

Jun 12 2019 // Sponsor: Nevakar, LLC Principal Investigator: Melanie Schmitt, MD Study Coordinator: Angie Adler Study Objective: In stage 1, the purpose of this study is to evaluate the safety and efficacy of 2 concentrations of NVK-002 compared… Read More

A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia (CHAMP)

Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) APL2-304 OAKS

Jun 12 2019 // Sponsor: Apellis Pharmaceuticals, Inc. Principal Investigator: Mihai Mititelu, MD Study Coordinator: Chris Smith Study Objective: This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple… Read More

Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) APL2-304 OAKS

A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)

Jun 12 2019 // Sponsor: Graybug Vision Principal Investigator: Jonathan Chang, MD Study Coordinator: Angie Adler  Study Objective: The purpose of this study is to evaluate the safety and duration of repeated IVT injections of 3 dose levels of… Read More

A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)

Ocugen Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

Jan 28 2019 // Sponsor: Ocugen, Inc Principal Investigator:  Evan Warner Study coordinator: Angie Adler or Kris Dietzman Study Objective: To evaluate the safety, tolerability, and efficacy of Brimonidine Nanoemulsion eye drops in patients with ocular Graft vs Host… Read More

Ocugen Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

Hoffman-LaRoche YOSEMITE for Diabetic Macular Edema Study

Jan 28 2019 // Protocol No.: GR40349 Sponsor: F. Hoffmann-La Roche Ltd A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients With Diabetic Macular Edema (YOSEMITE) Brief Summary: This… Read More

Hoffman-LaRoche YOSEMITE for Diabetic Macular Edema Study

AMD Ryan Initiative Study (ARIS)

Jan 28 2019 // Sponsor: National Eye Institute Principal Investigator:  Barbara Blodi Study coordinator: Kris Dietzman Study Objective: Enhancing the understanding of the natural history of early AMD and RPD. Eligibility: People ages 55 and older with any of… Read More

AMD Ryan Initiative Study (ARIS)

Retinal Gene Therapy for Choroidermia

Jul 16 2018 // NSR-REP-01 STAR Clinical Trial of Retinal Gene Therapy for Choroideremia Sponsor: Night Therapeutics Principal Investigator: Kimberly Stepien, MD Study Coordinator: Nickie Stangel Study Objective: To evaluate the efficacy and sagety of a single subretinal injection… Read More

Retinal Gene Therapy for Choroidermia

Inherited Ocular Disease Recruitment Registry

Jul 16 2018 // Inherited Ocular Disease Recruitment Registry Multicenter Observational Study of X-Linked Retinitis Pigmentosa. Principal Investigators: Kim Stepien, MD Co-investigator: Melanie Schmitt, MD Study Coordinator: Nickie Stangel Study Objective: To have an on-site repository of potential study… Read More

Inherited Ocular Disease Recruitment Registry

Binocular Dig Rush Game Treatment for Amblyopia

Feb 12 2018 // Binocular Dig Rush Game Treatment for Amblyopia (PEDIG ATS20 Protocol) Sponsor: National Eye Institute (NEI) Principal Investigator: Yasmin Bradfield, MD Study Coordinator: Angie Adler Study Objective: To compare the efficacy of 1 hour/day of binocular… Read More

Binocular Dig Rush Game Treatment for Amblyopia

Natural History of the Progression of X-Linked Retinitis Pigmentosa Study

Feb 12 2018 // Natural History of the Progression of X-Linked Retinitis Pigmentosa Study (NSR-XLRP-OS1) Multicenter Observational Study of X-Linked Retinitis Pigmentosa. Sponsor: Night Therapeutics Principal Investigator: Kim Stepien, MD Study Coordinator: Nickie Stangel Study Objective: To gain a… Read More

Natural History of the Progression of X-Linked Retinitis Pigmentosa Study

Natural History of the Progression of Choroideremia Study

Feb 12 2018 // Natural History of the Progression of Choroideremia Study Multicenter Observational Study of Choroideremia Sponsor: Night Therapeutics Principal Investigator: Kim Stepien, MD Study Coordinator: Nickie Stangel Study Objective: To assess the rate of progression of choroideremia… Read More

Natural History of the Progression of Choroideremia Study

Zoster Eye Disease Study (ZEDS)

Feb 07 2018 // Zoster Eye Disease Study (ZEDS) A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis… Read More

Zoster Eye Disease Study (ZEDS)

ARTISAN® Aphakia Lens

Feb 07 2018 // ARTISAN® Aphakia Lens Investigational Plan for the Clinical Study of the ARTISAN® Aphakia Lens for the Correction of Aphakia in Children Study Sponsor: OPHTEC USA, Inc. Principal Investigator: Yasmin Bradfield, MD Study Coordinator: Kris Dietzman… Read More

ARTISAN® Aphakia Lens

Pedig IXT1

Feb 14 2017 // sponsored by JAEB PEDIG ~ Intermittent Exotropia Study 1: A Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia Primary Investigator: Yasmin Bradfield, MD Study Coordinator: Angie… Read More

Pedig IXT1

NTMT

Feb 14 2017 // sponsored by Lowy Medical Research Institute (This trial is no longer enrolling) A PHASE 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangeictasia Type 2 (MacTel) Sponsor: Neurotech USA, Inc Principal Investigator: Barbara… Read More

NTMT

Molecular Genetics of Myopia

Feb 14 2017 // sponsored by National Institutes of Health   Principal Investigator: Terri young Coordinator: Angie Adler The purpose of the study is to identify the genes that are involved in eye growth specifically in individuals and families… Read More

Molecular Genetics of Myopia

Clinical and Molecular Analysis of Genetic Eye Disorders

Feb 14 2017 // sponsored by Privately Funded Source Principal Investigator: Terri Young Coordinators: Emily Higuchi and Angie Adler The purpose of this study is to identify the gene or genes responsible for developmental causes of blindness in the world.… Read More

Clinical and Molecular Analysis of Genetic Eye Disorders