Clinical Trials

The Vision Research Coordinating Center (VRCC) is a joint collaboration between the UH Eye Institute and the CWRU Department of Ophthalmology and Visual Sciences. The center was established in 2004 to coordinate all ophthalmic clinical trials contracted through UH or CWRU. Descriptions of some of the current clinical trials are listed below, categorized by area:

Cornea

A Multi-Center Study to Map Novel Genes for Fuch’s Endothelial Corneal Dystrophy (FECD)-not currently enrolling

PI: Jonathan Lass, MD
Sponsor: NIH
Coordinator: Kalisha Washington
216.844.7307

Cornea Donor Study (CDS)- enrollment closed

PI: Jonathan Lass, MD
Sponsor: NIH
Coordinator: Kalisha Washington
216.844.7307

Effect of Corneal Preservation Time on Long-Term Graft Success Cornea Preservation Time Study (CPTS)-currently enrolling

PI: Jonathan Lass, MD
Sponsor: NIH
Coordinator: Kalisha Washington
216.844.7307

A Randomized, Prospective, Double-Masked Clinical Trial of Life 4ºC Versus Optisol GS Corneal Storage Media (Life 4ºC)- not currently enrolling

PI: Jonathan Lass, MD
Sponsor: Ophthalmology Dept.
Coordinator: Lisa Ferguson
216.844.7658

Retina

ACCORDION:The ACCORD (Action to Control Cardiovascular Risk in Diabetes)Follow-On Study- enrolling previous ACCORD subjects only

PI: Johnny Tang, MD
Sponsor: NIH
Coordinator: Cherie Hornsby, RN
216.844.7408

Age-Related Macular Degeneration Study 2 (AREDS2)- enrollment closed

PI: Suber S. Huang, MD, MBA
Sponsor: NIH
Coordinator: Cherie Hornsby, RN
216.844.7408

Blood and Saliva Sample Collection and Submission to the Age-Related Eye Disease Study 2 (AREDS2) Genetic Repository- enrolling current AREDS2 subjects only

PI: Suber S. Huang, MD, MBA
Sponsor: NIH
Coordinator: Cherie Hornsby, RN
216.844.7408

Detecting Diabetic Retinopathy in At-Risk Populations using the PanOptic Ophthalmoscope: Evaluating the Accuracy of Non-Mydriatic Direct Ophthalmoscopy by Non-Specialists Versus Analysis of Dilated Fundus Photographs- currently enrolling

PI: Suber S. Huang, MD, MBA
Sponsor: Ophthalmology Dept.
Coordinator: Juewon Khwarg
216.844.7408

DRCR.net Genes in Diabetic Retinopathy Study- enrolling current/past DRCR.net subjects only

PI: Suber S. Huang, MD, MBA
Sponsor: NIH
Coordinator: Cherie Hornsby, RN
216.844.7408

The Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control (DRCR.net Protocol M)- enrollment closed

PI: Suber S. Huang, MD, MBA
Sponsor: NIH
Coordinator: Cherie Hornsby, RN
216.844.7408

An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (DRCR.net Protocol N)- enrollment closed

PI: Suber S. Huang, MD, MBA
Sponsor: NIH
Coordinator: Cherie Hornsby, RN
216.844.7408

Home Vision Monitoring for Progression to Neovascular AMD Using the ForeseeHome Device- currently enrolling

PI: Suber S. Huang, MD, MBA
Sponsor: Notal Vision, Ltd.
Coordinator: Nyesha Smith
216.983.5254

Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema (DRCR.net Protocol I)- enrollment closed

PI: Suber S. Huang, MD, MBA
Sponsor: NIH
Coordinator: Cherie Hornsby, RN
216.844.7408

A Phase II Evaluation of Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)on Eyes with Non-Central Involved Diabetic Macular Edema (DRCR.net Protocol R)- currently enrolling

PI: Shawn Wilker, MD
Sponsor: NIH
Coordinator: Cherie Hornsby, RN
216.844.7408

Contact Lens

1-Day Acuvue® Tru-Eye™ Brand Contact Lenses & 1-Day Acuvue® Moist® Brand Contact Lenses with LACREON® TECHNOLOGY Daily Disposable Performance Registry- TEMPO Study-currently enrolling

PI: Loretta Szczotka-Flynn, OD, Ph.D
Sponsor: Johnson & Johnson
Coordinator: Sangeetha Raghupathy
216.844.8552

Infiltrative Events During Silicone Hydrogel Daily Contact Lenses (DWCIE- Daily-Wear Corneal Infiltration Event)- enrollment closed

PI: Loretta Szczotka-Flynn, OD, Ph.D
Sponsor: Alcon
Coordinator: Sangeetha Raghupathy
216.844.8552

A Prospective, Randomized, Open Label Clinical Trial on the Association Between Mucin Balls and the Development of Corneal Infiltrative Events During ExtendedWear with Silicone Hydrogel Contact Lenses-currently enrolling

PI: Loretta Szczotka-Flynn, OD, Ph.D
Sponsor: Vistakon, Johnson & Johnson
Coordinator: Sangeetha Raghupathy
216.844.8552

Role of Mucin in Contact Lens-Induced Corneal Infiltrates- enrollment closed

PI: Loretta Szczotka-Flynn, OD, Ph.D
Sponsor: Vistakon
Coordinator: Sangeetha Raghupathy
216.844.8552

Pediatric Ophthalmology

A Pilot Study to Determine Feasibility of Non-Invasive Measurement of Retinal Blood Flow in Severe Low Birth Weight Infants (LDF4ROP)- enrollment to begin Summer 2012

PI: Suber S. Huang, MD, MBA
Sponsor: UH/CWRU/NASA
Coordinator: Cherie Hornsby, RN
216.844.7408

Other

Analysis of Intraocular and Serum Cholesterol Profiles in Patients Undergoing Cataract Surgery: A Pilot Study- currently enrolling

PI: Irina Pikuleva, Ph.D
Sponsor: Ophthalmology Dept.
Coordinator: Nyesha Smith
216.983.5254

Therapeutic Effects of Cataract Removal in Alzheimer’s disease- currently enrolling

PI: Grover C. Gilmore, Ph.D
Sponsor: NIH.
Coordinator: Tatiana Riedel
216.368.6465