Home / Research / Clinical Trials
How can you help?

 

Cornea and External Disease Studies

 

Fuchs’ Endothelial Corneal Dystrophy Genetics Study (FECD)

Sponsor: National Eye Institute
Site Investigator: Jonathan H. Lass, MD
Co-Investigators: William J. Reinhart, MD
Status: Enrollment open

The purpose of this multi-center study coordinated by the Case Vision Research Coordinating Center is to determine the genetic basis for the most common corneal dystrophy in the United States, Fuchs' Endothelial Corneal Dystrophy.  Severely affected patients who have undergone corneal transplantation for this disease are asked to contact their siblings to also be screened for the disease and have their blood drawn for genetic analysis to determine which gene(s) may have an influence in the development of the disease.

 

Cornea Donor Study (CDS)      

Sponsor: National Eye Institute
Site Investigators: Jonathan H. Lass, MD; William J. Reinhart, MD
Status: Enrollment closed

This national study, involving 1101 patients is designed to determine whether the age of the donor cornea influences how long the corneal transplant stays clear following corneal transplantation.  With a shrinking donor pool, it will be important to determine whether corneas from 65 to 75 year old donors can be used in younger patients successfully.  5 year results will not be available until 2007 with plans now for ten year results in 2012.  This study is coordinated by the Jaeb Center for Health Research in Tampa, Florida.

 

Deep Lamellar Endothelial Keratoplasty (DLEK) Study

Investigator: William J. Reinhart, MD
Status: Enrollment closed

This research project is designed to determine if the surgical procedure DLEK is able to reduce the degree of corneal astigmatism and shorten the time of corneal topography stabilization as compared to penetrating keratoplasty in patients suffering from endothelial failure of the cornea.

 

Evaluation of the Utility of Intra-Operative Topography to Optimize Corneal Shape During Penetrating Keratoplasty

Sponsor: National Eye Institute
Site Investigator: William J. Reinhart, MD
Co-Investigators: Jonathan H. Lass, MD
Status: Enrollment closed

The purpose of this study is to compare the clinical outcome of penetrating keratoplasty when intraoperative rasterstereography corneal topography is used to PKP outcomes when rasterstereography is not used.  

 

Retina-Vitreous Studies

 

ACCORD Eye Study

Sponsor: National Institutes of Health
Site Investigators: Julie K. Belkin, MD; Suber S. Huang, MD, MBA
Co-Investigator: Michael C. Heeg, MD
Status: Enrollment closed

ACCORD-EYE is a research study to determine whether or not intensive therapy or control of blood glucose, blood pressure, and lipids will reduce the development and progression of diabetic retinopathy. Retinopathy associated with diabetes is the leading cause of acquired blindness in adults in the US. The ACCORD- EYE Study will involve a group of 4,065 people with diabetes already participating in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study.

 

An Exploratory randomized, double-masked, multi-center, multi-dose, comparative trial, in parallel groups, to explore the safety and efficacy of three different doses of intravitreous injections of pegaptanib sodium (Anti-VEGF Pegylate Aptamer) given every 6 weeks for 102 weeks, in subjects with subfoveal neovascular Age-Related Macular Degeneration (AMD)

Sponsor: OSI Eyetech
Site Investigator: Suber S. Huang, MD, MBA
Co-Investigator: Michael C. Heeg, MD
Status: Enrollment open

The purpose of this study is to compare three different doses of MacugenŽ (0.003, 0.03, and 0.3 mg), to find out which dose is the most safe and effective for patients with Age-Related Macular Degeneration (AMD).

 

An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

Sponsor: Bausch and Lomb
Site Investigator: Suber S. Huang, MD, MBA
Co-Investigator: Michael C. Heeg, MD
Status: Enrollment open

The purpose of this research study is to test the safety and effectiveness of different doses of a medication called plasmin to cause a separation of the vitreous (the gel inside the eye) from the retina (the layer of cells at the back of the eye that allows you to see).  The drug is injected into the vitreous of the eye.  Creating a PVD in this controlled manner before having a surgery called a vitrectomy, when the vitreous is removed from the back of the eye, may make the surgery easier and avoid complications after the surgery.

 

Diabetic Retinopathy Clinical Research Network (DRCRnet)

Sponsor: National Eye Institute
Site Investigator: Suber S. Huang, MD, MBA
Co-Investigator: Michael C. Heeg, MD
Protocol #1 A: A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema
Status: Closed - no longer accepting patients
Protocol #2: A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
Status: Enrollment closed

The Department of Ophthalmology serves as one of over 100 participating sites for the DCRC Network directed by the Jaeb Center for Health Research.  This National Eye Institute funded network exists to evaluate promising treatment approaches for diabetic macular edema.

 

The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide with Standard Care to Treat Macular Edema

Sponsor: National Eye Institute
Site Investigator: Suber S. Huang, MD, MBA
Co-Investigator: Michael C. Heeg, MD
Status: Enrollment open

The purpose of the study is to find out if injection(s) of steroid into the eye are safe and effective in the treatment of macular edema for people suffering from branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) compared to the standard laser treatment.

 

Other Areas of Interest

 

Vision Research Coordinating Center (VRCC)

Sponsor: National Eye Institute and corporate funding
Director: Jonathan H. Lass, MD
Co-Investigators: Suber S. Huang, MD, MBA; Sara Debanne, PhD; Mireya Diaz-Insua, PhD; Sudha Iyengar, PhD
Status: Clinical Research Submissions Welcome

The Vision Research Coordinating Center (VRCC) was created in 2004 through funding by a vision research infrastructure grant from the National Eye Institute at the National Institutes of Health.  It also receives support via pharmaceutical corporate funding.  The Center is housed in the Department of Ophthalmology at the Case Medical Center in Cleveland, Ohio. The VRCC's mission is to coordinate multi-center trials to translate basic science discoveries developed in the Visual Sciences Research Center that may provide new methods to prevent or treat blinding diseases. The Center also coordinates federal and corporate-initiated trials for studies where the Department services as a site.  The VRCC is staffed by its director and Department of Ophthalmology Chairman, Dr. Jonathan H. Lass, two biostatistician/epidemiologists, the Vice Chair of the Department, Dr. Suber S. Huang, overseeing corporate trials, 4 clinical coordinators, and a database manager. 

 

Retinal Diseases Image Analysis Reading Center (REDIARC)

Medical Director: Suber S. Huang, MD, MBA
Technical Director: Beth Ann Benetz, CRA, MFA
Status: Enrollment open

 

 

Specular Microscopy Reading Center (SMRC)

Medical Director: Jonathan H. Lass, MD
Technical Director: Beth Ann Benetz, CRA, MFA
Status: Enrollment open

Organized with a medical director, technical director and two certified technicians to perform dual grading and adjudication of endothelial images for image quality and endothelial cell count determination.  Also capable of morphometric analyses of endothelial images.  

 

Specular Microscopy Ancillary Study (SMAS)

Medical Director: Jonathan H. Lass, MD
Technical Director: Beth Ann Benetz, CRA, MFA
Status: Enrollment closed

The Specular Microscopy Ancillary Study (SMAS), is an ancillary study of the Cornea Donor Study (CDS) (see above).  It is examining the effect of donor age of long-term endothelial survival five to ten years after penetrating keratoplasty.  A recent published study by the SMRC, as a result of the SMAS noted that the accuracy of cell counting by eye banks participating in SMAS was good but there remains room for improvement with 30% of the counts greater or less than the SMRC count (Ophthalmology 112:431-440, 2005).

 

Clinical research activities are coordinated through the Vision Research Coordinating Center. If you are interested in any of the above studies or want information about whether a specific interest is anticipated as part of a clinical trial, please contact Lori Karpinecz, Patrick Lyons or Marie Norell at 216-844-7408 or lori.karpinecz@uhhs.com, patrick.lyons@uhhs.com or marie.norell@uhhs.com

 
 
Home | Contact Us