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.

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

Bonnie Verges

Research Technician and Photographer

Christopher M. Smith

Study Coordinator and Photographer

Age-Related Macular Degeneration

Status: Active

AMD Ryan Initiative Study (ARIS)

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Status: Active

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)

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Status: Active

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

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Status: Active

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

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

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Status: Active

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)

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Status: Active

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

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Diabetic macular edema (DME)

Status: Active

Hoffman-LaRoche YOSEMITE for Diabetic Macular Edema Study

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Status: Active

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

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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Status: Active

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

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)

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Inherited Retinal Diseases

Status: Active

Clinical and Molecular Analysis of Genetic Eye Disorders

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Status: Active

Natural History of the Progression of Choroideremia Study

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Status: Active

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

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Status: Active

Inherited Ocular Disease Recruitment Registry

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Status: Active

Retinal Gene Therapy for Choroideremia

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Clinical Trials by Study Indication

Age-related macular degeneration (AMD)

  • ARIS – COVID hold on recruitment
  • BIM 2 – Recruiting
  • Pulsar – Recruiting
  • Talon – COVID hold on recruitment
  • NORSE – In follow up (not recruiting)

AMD and DME

  • ICON (Roche) Survey trial – In start up (recruiting soon)

Branch retinal vein occlusion (BRVO)

  • RAPTOR – COVID hold on recruitment

BRVO and CRVO

  • SCORE2 – In follow up (not recruiting)

Central retinal vein occlusion (CRVO)

  • RAVEN – COVID hold on recruitment

 

Chorideremia

  • STAR – In follow up (not recruiting)
  • proNIGHT – In follow up (not recruiting)

Diabetic macular edema (DME)

  • Yosemite extension GR41987- In start up (recruiting soon)
  • Photon – In start up (recruiting soon)
  • Yosemite – In follow up (not recruiting)
  • Kestrel – In follow up (not recruiting)
  • Kingfisher – In follow up (not recruiting)

Geographic atrophy

  • GALLEGO – Recruiting
  • Catalina MGN – In start up (recruiting soon)
  • Gallego extension GR42558 – In start up (recruiting soon)
  • DERBY – In follow up (not recruiting)
  • OAKS – In follow up (not recruiting)

 

Inherited Retinal Diseases

  • XOLARIS-XLRP (X-Linked Retinitis Pigmentosa) – Recruiting
  • SOLSTICE – XLRP (X-Linked Retinitis Pigmentosa ) – Recruiting
  • ProEYS – In start up (recruiting soon)
  • AGTC B3 – In start up (recruiting soon)
  • NAC Attack – In start up (recruiting soon)
  • Biogen survey trial – In start up (recruiting soon)

Melanoma

  • Aura Biosciences – Choroidal Melanoma – In start up (recruiting soon)

Other

    • AAOAI- Artifact in OCTA – COVID hold on recruitment
    • NTMT – Macular telangiectasia – In follow up (not recruiting)

Pediatrics

  • JIA Microbiome – In start up (recruiting soon)
  • ATS20 – In follow up (not recruiting)
  • CHAMP – In follow up (not recruiting)
  • IXT1 – In follow up (not recruiting)

Uveitis

  • Santen Lumina – Recruiting
  • Humbolt Gilead – Recruiting

Zoster eye disease

  • ZEDS – Recruiting

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

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