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:

Completed studies led by the CPOB Coordinating Center:

  • 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!