Retina Associates of Cleveland, Inc. : Research/Clinical Trials

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Clinical Trials and Research
We feel strongly about participation in clinical research and are dedicated to exploring newer and better treatment options for our patients. Our physicians and nurses are available to discuss participation in clinical trials and whether it is right for you.
Diane W., RN, BSN
Diane graduated from BGSU, working 7 yrs in Med/Surg and Home Care, then 15 yrs at Mt. Sinai as a Clinical Specialist/Practice Manager of the Eye Clinic and coordinator for the Ophthalmology Residency program. Diane joined RACI in 1999 and serves as the Sr. Clinical Nurse and Study Coordinator.
Kimberly D., LPN, CCRP
Kimberly has worked in ophthalmology since 1984, and started at Retina Associates of Cleveland in 1994. While at Retina Associates she has worked as a Technician assisting the physicians, coordinated multiple clinical trials and manages the Low Vision Resource Center, located in the Beachwood office.
Dianne H., RN, BSN, CCRC
Dianne has been an RN since 1984. She started clinical research with the Cleveland Clinic in 1997, and in 1991 received her certification as a Clinical Research Nurse. Dianne joined Retina Associates of Cleveland in 2006. She has personally coordinated over 50 clinical trials.
Lori R., COA
Lori is a Certified Ophthalmic Assistant and has worked for RACI since 1990. She is a Photographer/Technician who has worked with several clinical trials over the years as both a Clinic Coordinator and Study Photographer.
Larraine (Rae) S., RN, BA, CCRC
Larraine (Rae) S., RN, BA, CCRC has been an RN since 1984 and a Clinical Research Nurse since 1988. Rae also holds a BBA from Baldwin Wallace. She was employed by UH for 17 years with experience in multiple disciplines and the Cleveland Clinic for 5 years. Rae joined RACI in 2007 and is certified as a Clinical Research Coordinator.
Susan R., PA-C
Susan has been working at RACI since 1988. She has worked in the office, operating room, and in clinical research, and for the last 10 years has had a main focus in Clinical Drug Research. Susan said that the most gratifying aspect of clinical drug research is participating in a study in which the drug proves to be beneficial for patients and obtains FDA approval.
Tammy B., MA/COA
Tammy has been with Retina Associates of Cleveland since 2001 as clinical technician/study refractor/study coordinator. She worked in general ophthalmology for 10 years prior to joining RACI.
Trina N., COT
Trina has been working in Ophthalmology since 1991. She has been employed with Retina Associates of Cleveland since 2003. Her background in Ophthalmology includes working as a Technician, a Clinical Research Coordinator and as a Study Photographer. Trina likes to be active in local and national ophthalmology organizations.
Vivian T., CCRP, COT
Vivian has been a Certified Clinical Research Professional since 2003. In addition, she has experience in multiple disciplines: 33 years experience as a Certified Ophthalmic Technician, 25 years experience as a Clinical Research Coordinator, 18 years experience as an Ultra-sonographer and 25 years as an Electroretinographer. Vivian has been with Retina Associates of Cleveland since 1993.

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Research & Clinical Trials

Study Detail: Lux Uveitis

Trial Description
Summary : Study of Vocolosprin Soft Gel Capsules in the treatment of active noninfectious intermediate, posterior or pan-uveitis.

Basic Trial Information
Phase: III
Disease: Uveitis
Status: Pending Start-up for Dec 2010
Age: 18 or older
Sponsor: LuxBio Sciences
Protocol Number: LX211-11
Study Duration: 6 months

Eligibility Criteria
Inclusion Criteria
      Active non-infectious uveitis involving the intermediate and/or posterior segment in at least one eye as evidenced by vitreous haze grade of at least 2+.
      Must have current uveitis therapy which consists of Prednisone monotherapy between 10-40 mg/day for at least 2 weeks or Prednisone at any dose in addition to one immunomodulatory agent of either cyclosporine, tacrolimus, azathiprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks.
      Visual Acuity of at least CF at one foot in both eyes

Exclusion Criteria
     Uveitis limied to only the anterior segment
      Confirmed or suspected infectious uveitis in either eye
      Active infection in either eye
      Proliferative or severe non-proliferative diabetic retinopathy in either eye
      Neovascular or wet AMD in either eye
      Abnormalities of the vitreo-retinal interface in the study eye thought to interfere with assessment
      Multiple general health exclusionary criteria including but not limited to the following: renal and liver function abnormalities, severe anemia, prescence of certianinfectious diseases, elevated blood pressure, baseline ECG abnormalities and body weight of less than 84 pounds.

Study Title

A Multi-center, Double-Masked, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Vocolosporin as Therapy in Subjects with Active Noninfectious Intermediate, Posterior or Pan-uveitis.

Trial Contact Information
Site Locations: Beachwood or Middleburg Hts.
Study Coordinator: 216/831-5704 ext. 253

Clinical Trials and Research

Diane W., RN, BSN

Kimberly D., LPN, CCRP

Dianne H., RN, BSN, CCRC

Lori R., COA

Larraine (Rae) S., RN, BA, CCRC

Susan R., PA-C

Tammy B., MA/COA

Trina N., COT

Vivian T., CCRP, COT