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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Age-related Macular Degeneration

Diabetic Retinopathy

Retinal Vein Occlusion

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Research & Clinical Trials

Study Detail: Allergan RVO VO1

Trial Description Summary
A 12 month Phase 2, Masked-Randomized Single Dose Study of the Safety and Efficacy of AGN-208397 (Beclomethasone Dipropionate) in Patients with ME associated with RVO.

Basic Trial Information
Phase: II
Disease Status: Retinal Vein Occlusion
Age: 18 or older
Sponsor: Allergan
Protocol #: 208397-001
Status: Enrolling
Study Duration: 1 year

Eligibility Criteria:
OPHTHALMIC INCLUSION-
• Non-ischemic BRVO or CRVO with ME involving the center of the macula (fovea) with vision decrease attributable to the ME
• CRVO- duration of < 9 months or BRVO- duration of < 12 months
• Central Sub-field Cirrus OCT = 300 µm (Stratus OCT = 275 µm)
• BCVA approx. 20/320-20/40
OPHTHALMIC EXCLUSION-
• IOP >21 or glaucoma in either eye at screening or baseline, or in the past
• Hx of Laser Photocoagulation to the SE within 3 months of Baseline
• Hx of Intravitreal Injectable Drug other than corticosteroids in the SE within 2 months of Baseline
• Hx of Intravitreal or Periocular Corticosteroids within 4 months of Baseline
• Hx of systemic (oral, Intavenous, IM, epidural, rectal, inhaled, or extensive dermal) corticosteroids within 3 months of Baseline
• FE approx. 20/200 or worse
• Current or hx of ocular disease in the SE that may confound assessment or affect central vision (for example: CNV-AMD, GA, DR, Uveitis, Angioid Streaks, CSR, Histo, Pathologic Myopia, RD, ERM, Mac Hole or Significant Cataract.
• Any active ocular inflammation or infection at screening or hx of toxo or cytomegalovirus or herpes infection in either eye
• Aphakia or violation of the PC unless it occurred as result of YAG in associated with prior PCIOL.
• Hx of PK or Vitrectomy
• Cataract or LASIK surgery within the last 3 months
• Plans for cataract extraction in the next year
GENERAL MEDICAL EXCLUSION-
• Uncontrolled systemic disease

Other inclusion/exclusion criteria as outlined in the protocol will be screened by the study coordinator

Study Title
A 12-Month, Multicenter, 2-Stage (Open Label, Dose-Escalation, Followed by Masked, Randomized) Single Dose Study of the Safety and Efficacy of AGN-208397 in Patients with Macular Edema (ME) Associated with Retinal Vein Occlusion (RVO)

Trial Contact Information
Site: Beachwood
Study Coordinator: Kim DuBois
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