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: Ophthotech 1001

Trial Description Summary : Controlled trial for safety and efficacy of intravitreal injection of E10030 (anti-platelet derived growth factor {anti-PDGF}) given in combination with Lucentis in patients with treatment naive CNV from AMD.

Basic Trial Information
Phase: 2
Disease: Macular Degeneration (wet form)
Sponsor: Ophthotech Corp.
Protocol Number: OPH1001
Status: Enrolling

Study Duration: 24 weeks (9 visits)

Eligibility Criteria:
       Inclusion Criteria
              CNV is predominately classic or minimally classic
               BCVA 20/63-20/200
               Total lesion greater than, or equal to 5 disc areas of which 50% must be active
              OCT Cirrus > 300 or Status > 250
             IOP < 21
               Clear ocular media for photo evaluation
      Exclusion Criteria
            Ophthalmic
                  Any prior treatment for AMD (other than vitamins/minerals)
                  Any prior intravitreal treatment in study eye, regardless of indication
                  >25% of lesion made up of scar or atrophy
                  >50% of lesion made up of SRH (sub retinal hemorrhage)
                  RAP lesions
                  Presence of significant PEDs
                  Any intraocular surgery or thermal laser within 3 months of the trial
               Any prior thermal laser in the macular region for any indication
                Aphakia
                  Any ocular or periocular infection in the past 12 weeks
            General Medical
                  Diabetes
                  Severe cardiac disease
                 MI in past 6 months
                 CVA within 12 months
                  Major surgery within one month
                  Clinically significant renal or hepatic disease
                  Any treatment with investigational agent within one month of trial entry

The above inclusion/exclusion criteria is not complete and the study coordinator will do a complete screening.

Study Title : A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination with Lucentis in Subjects with Neovascular Age-Related Macular Degeneration

Trial Contact Information
Site: Beachwood
Study Coordinator: Diane W. @ 216/831-5700

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