Perelman School of Medicine at the University of Pennsylvania

Center for Preventive Ophthalmology and Biostatistics (CPOB)

Coordinating Center

The Center for Preventive Ophthalmology and Biostatistics has been the home for the coordinating centers of several multicenter studies sponsored by NIH or industry.

What is a Coordinating Center?

The particular functions performed by a Coordinating Center may vary among studies, but in general, a Coordinating Center is a centrally located resource center that provides the administrative, clinical and technical expertise and leadership in the design and coordination of a collaborative multi-center trial.  Coordinating Center staff are responsible for all site monitoring and for the coordination of subject recruitment, screening, enrollment and retention, data and safety monitoring, data collection and analysis, adherence to the protocol-directed procedures and guidelines, and the prompt review and reporting of adverse events.  Coordinating Centers receive, validate, store and analyze clinical trial data, prepare reports to Data and Safety Monitoring Committees, and generate random assignments to treatment groups after patients have consented to enter a clinical trial.  For more information on Coordinating Center services, click here.

Ongoing Studies in the CPOB Coordinating Center:

  • DREAM: The DRy Eye Evaluation And Management (DREAM) Study is a multi-center, double masked randomized clinical trial that is funded by the National Eye Institute to evaluate the efficacy and safety of omega 3 fatty acids (fish oil) compared to placebo in patients with mild to moderate dry eye disease (DED).  Click here for more information about the DREAM study.
  • FLAME: The FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial is a randomized, double-masked, placebo controlled clinical trial that is funded by the National Eye Institute.   The study is designed to assess the efficacy and safety of fluorometholone vs. placebo eyedrops as ancillary therapy for patients in Ethiopia with trachomatous trichiasis (TT) who are undergoing lid rotation/correction surgery.  Click here for more information about he FLAME study.
  • G-ROPThe G-ROP studies are two large-scale multi-center studies, sponsored by the National Eye Institute, to develop a ROP prediction model on a retrospective cohort (n=7,483) and validate the prediction model on a prospective cohort (n=4,393) using postnatal weight gain to identify infants with severe ROP.  Click here for more information about the G-ROP studies.

Completed studies led by the CPOB Coordinating Center:

  • Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) is a set of multicenter, randomized clinical trials of treatments for neovascular age-related macular degeneration (AMD), the leading cause of blindness in the United States.  The Lucentis-Avastin Trial, supported by the National Eye Institute will be the first CATT clinical trial.  Click here for more information about the CATT Study.
  • Telemedicine Approaches to Evaluating Acute-phase Retinopathy of Prematurity (e -ROP) Study is a multi-center study designed to evaluate the validity, reliability, feasibility and cost-effectiveness of a telemedicine system to detect eyes of at-risk babies in need of a diagnostic examination by an ophthalmologist experienced in retinopathy of prematurity (ROP).  The study is funded by the National Eye Institute of NIH.  Click here for more information about this study
  • IDx-DR
  • Retinopathy in Chronic Renal Insufficiency (RCRIC) Study (RCRIC) is a multi-centered research study that will investigate the effect that chronic kidney disease has on the eyes.  The study involves photographing the retinas of people with chronic kidney disease.  The information gathered from the photos will help researchers better understand the relationship between kidney disease, heart disease, and eye conditions.  CPOB serves as both the Coordinating Center and Reading Center for the RCRIC study, which is funded by the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK). Click here for more information about this study.
  • The Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study (Scleritis Study) is a randomized clinical trial designed to evaluate the safety and provide a preliminary assessment of the effectiveness of a new drug used with a new drug delivery system to treat patients with anterior scleritis.  The sponsors of this study are the United States Food and Drug Administration (FDA), which is an agency that is part of the federal government, and EyeGate Pharmaceuticals, Inc. (EyeGate).  Click here for more information about this study.
  • The GALA Study is a multi-center, double masked randomized clinical trial that will evaluate alpha lipoic acid (ALA) as a potential treatment for geographic atrophy (GA) due to age related macular degeneration (AMD). It is funded by the BrightFocus Foundation, Cures Within Reach, and the Pennsylvania Lions.
  • Vision in Preschoolers (VIP) Study: VIP is an NEI-sponsored multicenter study to evaluate the accuracy of traditional and newly developed screening tests for detecting amblyopia, strabismus, and significant refractive error in preschool children.  Through a series of evaluation cycles, nearly 10,000 children will be tested through 5 clinical centers nationwide over a period of 5 to 6 years.  The CPOB serves as the Coordinating Center for the VIP study. Click here for more information about the VIP Study.
  • The Complications of Age-related Macular Degeneration Prevention Trial (CAPT): CAPT is an NEI-sponsored, randomized, clinical trial involving 23 clinical centers nationwide, 1000 patients, and an annual budget of $3 million.  The trial is evaluating laser treatment among patients at high risk of developing severe loss of vision from age-related macular degeneration, the leading cause of blindness in the United States and many other western countries.  The CPOB serves as both the CAPT Coordinating Center and the CAPT Fundus Photograph Reading Center.  This trial is expected to be completed in 2006.  Click here for more information about the CAPT Study.
  • The Multicenter Uveitis Steroid Treatment Trial (MUST)
  • The Choroidal Neovascularization Prevention Trial (CNVPT 1994-2000): Sponsored in part by the National Eye Institute (NEI) was a pilot randomized trial of laser photocoagulation in eyes at high risk of choroidal neovascularization secondary to age-related macular degeneration.  The CNVPT included 276 patients, 15 clinical centers, and resulted in 6 peer-reviewed publications.
  • Age-Related Macular Degeneration Radiotherapy Trial (AMDRT 2000-2003): CPOB staff served as the Coordinating Center for the AMDRT, an NEI sponsored pilot study to evaluate the safety and feasibility of conducting a large-scale trial of radiotherapy for eyes with neovascular AMD.  The AMDRT included 88 patients, 10 clinical centers and resulted in one peer reviewed publication.  AMDRT involved coordination of patient visits to multiple medical specialty services.  Results of the pilot study did not support a full-scale trial.

Coordinating Center Staff

For each clinical trial, a multidisciplinary team is assembled, comprised of Biostatisticians, Project Directors, Systems Analyst, Programmers and Protocol Monitors to develop protocols and procedures to best meet the individual needs of the study.  Often, the studies require collaboration with the Scheie Image Reading Center (SIRC).  Click here to learn more about the Coordinating Center staff.

For additional information, contact us!