Clinical Eye Research Unit

The Clinical Eye Research Unit (CERU) at the University of Wisconsin – Madison Department of Ophthalmology and Visual Sciences (DOVS) 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.

The DOVS has been, and continues to be, at the forefront of vision research. CERU is inextricably linked to this success, providing researchers all over the world 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. We have been at the forefront of many of these including AREDS, AREDS 2, SCORE, SCORE 2, DRCRnet trials, Pedig pediatric trials, CAPT, and CATT. Many of these trials reveal important data for safe and effective treatments for eye diseases and vision loss.

While CERU serves as the primary clinical research team for DOVS, we actively collaborate studies that can affect the eye in any way. CERU is often involved in clinical trials initiated by departments within the UW–Madison School of Medicine and Public Health and extend all across campus, including UW Hospital and Carbone Cancer Center.

CERU provides top imaging and diagnostics technology for most ophthalmology-related trial needs. CERU has decades of experience coordinating trials for Phase I, II, III, and IV studies, anywhere from small, local investigator-initiated trials to large nationwide studies.

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.

The CERU 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

Clinical Eye Research Unit Team

Mihai Mititelu

Associate Professor, Medical Director of the Clinical Eye Research Unit

Jennie R. Perry-Raymond

Clinical Trials Administrator

608-265-4659

Angie M. Adler

Study Coordinator and Regulatory Specialist

608-265-7557

Kelly Boyd

CERU Study Coordinator

Brianna C. Julian

CERU Regulatory and Quality Assurance Specialist

Christopher M. Smith

Study Coordinator and Photographer

Bonnie Verges

Research Technician and Photographer

Darla Coullard

Study Coordinator, ERG specialist

Age-Related Macular Degeneration

Status: Active: Recruiting

ARIS

Age-Related Macular Degeneration Ryan Initiative Study (ARIS). Enhancing the understanding of the natural history of early AMD and RPD.

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Status: Active: Recruiting

GALLEGO

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)

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Status: Active: Recruiting

PULSAR

Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients with Neovascular Age-Related Macular Degeneration (PULSAR)

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Status: Active: Recruiting

TALON

A 64-week, two-arm, randomized, double-masked, multi-center, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in patients with neovascular age-related macular degeneration (TALON).

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Status: Active: Recruiting

CATALINA

A Phase II Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (CATALINA)

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Status: Active: Enrollment Closed

OAKS

A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled 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) (OAKS)

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Status: Active: Enrollment Closed

DERBY

A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled 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) (DERBY)

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Status: Active: Enrollment Closed

NORSE

A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects with Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) (NORSE)

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Status: Active: Enrollment Closed

BIM2

To identify whether genetic variation or polymorphism in genes that impact angiogenesis can be identified as biomarkers for responsiveness to anti-VEGF therapy in patients with neovascular age-related macular degeneration.

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Choroidal Melanoma

Status: Active: Recruiting

AURA

A Phase 2 Trial of AU-011 Via Suprachoroidal Administration with a Dose Escalation Phase (Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Dose Expansion Phase Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

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Cornea

Status: Active: Recruiting

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 Due to Herpes Zoster Ophthalmicus (HZO) in the Year Prior to Enrollment (ZEDS)

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Status: Active: Recruiting

oGVHD

Scleral Contact Lens Reduction of Dry Eye Inflammation in Patients with Graft-Versus-Host Disease (GVHD)

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Diabetic Macular Edema

Status: Active: Recruiting

PHOTON

A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients with Diabetic Macular Edema (PHOTON)

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Status: Active: Enrollment Closed

YOSEMITE

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients with Diabetic Macular Edema (YOSEMITE)

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Status: Active: Enrollment Closed

KESTREL

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)

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Status: Active: Enrollment Closed

KINGFISHER

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)

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Genetics

Status: Active: Recruiting

GENETIC EYE DISORDERS

To identify the gene or genes responsible for developmental causes of blindness in the world, and to establish a Pediatric Ophthalmic Genetics and Research Program at the University of Wisconsin – Madison.

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Status: Active: Recruiting

MYOPIA

To identify genes that are involved in eye growth specifically in individuals and families with nearsightedness (myopia).

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Inherited Retinal Diseases

Status: Active: Recruiting

SOLSTICE

A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects with Choroideremia Treated Previously with Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) in an Antecedent Study (SOLSTICE)

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Status: Active: Recruiting

AGTC B3

A Multiple-Site, Phase 1/2, Safety and Efficacy Trial of a Recombinant Adeno-associated Virus Vector Expressing CNGB3 (rAAV2tYF-PR1.7-hCNGB3) in Patients with Congenital Achromatopsia Caused by Mutations in the CNGB3 Gene

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Status: Active: Recruiting

AGTC A3

A Multiple-Site, Phase 1/2, Safety and Efficacy Trial of AGTC 402, a Recombinant Adeno-associated Virus Vector Expressing CNGA3, in Patients with Congenital Achromatopsia Caused by Mutations in the CNGA3 Gene

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Status: Active: Recruiting

Pro-EYS

Rate of Progression in EYS Related Retinal Degeneration (Pro-EYS).

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Status: Active: Recruiting

CHM SURVEY TRIAL

To assess health-related quality of life, health utility, work productivity, and impact on daily activities in patients/caregivers with CHM at different stages of disease progression.

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Status: Active: Recruiting

XOLARIS

To gain a better understanding of disease progression over time in male subjects with X-linked retinitis pigmentosa (XLRP).

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Status: Active: Enrollment Closed

STAR

A Randomized, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial of Retinal Gene Therapy For Choroideremia Using An Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1) (STAR)

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Status: Active: Enrollment Closed

NIGHT

Natural History of the Progression of Choroideremia Study (NIGHT).

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Other Explorations

Status: Active: Recruiting

MAC TEL

To evaluate long term safety and efficacy of the NT-501 implant in participants that previously enrolled in the NTMT-01 and NTMT-02 protocols.

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Status: Active: Recruiting

PRIM

To determine risk factors, prevalence, and incidence of maculopathy in UW patients with interstitial cystitis on pentosan polysulfate (PPS).

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Pediatrics

Status: Active: Recruiting

AS OCT

To investigate whether anatomical differences in Schlemm’s canal and anterior segment structures are associated with the development of glaucoma in pediatric patients that undergo cataract surgery.

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Status: Active: Enrollment Closed

INTERMITTENT EXOTROPIA STUDY (IXT1)

A Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia

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Status: Active: Enrollment Closed

AMBLYOPIA TREATMENT STUDY (ATS20)

Binocular Dig Rush Game Treatment for Amblyopia (ATS20)

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Status: Active: Enrollment Closed

CHAMP

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

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Retinal Vein Occlusion

Status: Active: Recruiting

RAPTOR

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)

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Status: Active: Recruiting

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 Central Retinal Vein Occlusion

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Status: Active: Enrollment Closed

SCORE2

A Multicenter, Prospective, Randomized Non-Inferiority Trial of Eyes with Macular Edema Secondary to Central Retinal Vein Occlusion, Comparing Intravitreal Bevacizumab Every 4 Weeks with Intravitreal Aflibercept Every 4 Weeks

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Uveitis

Status: Active: Recruiting

LUMINA

A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye (LUMINA)

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Status: Active: Recruiting

MICROBIOME

To compare the gut microbiota composition in pediatric Juvenile Idiopathic Arthritis (JIA) uveitis patients to JIA patients without uveitis and to healthy controls.

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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

Archived list of past clinical trials over the last 50 years as a leader in ophthalmic research is forthcoming.

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