title: SCORE2 Report 1: Techniques to Optimize Recruitment in Phase III Clinical Trials of Patients With Central Retinal Vein Occlusion.
abstract: OBJECTIVE
  To investigate recruitment rates of patients with central retinal vein occlusion (CRVO) into phase III clinical trials evaluating intravitreal pharmacotherapy for treatment of macular edema in the United States, describe recruitment techniques in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2), and assess which SCORE2 recruitment techniques were most useful to principal investigators and clinical coordinators.
  
  
  METHODS
  Retrospective survey within a randomized clinical trial.
  
  
  METHODS
  Recruitment rates of the Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE)-CRVO trial, CRUISE Study, and SCORE2 were calculated. Techniques employed to facilitate recruitment in SCORE2 are described, and a survey was sent to the principal investigator and primary clinical coordinator of each SCORE2 site to assess the usefulness of recruitment techniques.
  
  
  RESULTS
  In SCORE2, the recruitment rate of 0.39 participants/month/site was higher than in SCORE-CRVO (0.10 participants/month/site) and CRUISE (0.23 participants/month/site). For study design factors in SCORE2, investigators and coordinators rated provision of standard-of-care treatments to all study participants as having a major positive impact on recruitment. A monthly e-newsletter to site staff and communication by physician members of the SCORE2 Executive Committee to sites upon each randomization were perceived as effective means to help site staff focus on recruitment.
  
  
  CONCLUSIONS
  The SCORE2 recruitment rate compares favorably to previous clinical trials investigating intravitreal pharmacotherapy for treatment of CRVO-associated macular edema. Study design factors, methods of communication with sites, and recruitment techniques implemented in SCORE2 were well received by investigators and coordinators and may be helpful in future clinical trials.
authors.affiliation: Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
authors.forename: Ingrid U
authors.initials: IU
authors.lastname: Scott
authors.affiliation: The Emmes Corporation, Rockville, Maryland. Electronic address: pvanveldhuisen@emmes.com.
authors.forename: Paul C
authors.initials: PC
authors.lastname: VanVeldhuisen
authors.affiliation: University of Wisconsin Fundus Photograph Reading Center, Madison, Wisconsin.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Ip
authors.affiliation: University of Wisconsin Fundus Photograph Reading Center, Madison, Wisconsin.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Blodi
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Neal L
authors.initials: NL
authors.lastname: Oden
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Maria
authors.initials: M
authors.lastname: Figueroa
mesh_terms: D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000627:therapeutic use; D058015:Health Communication / Q000379:methods*; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy*; D010358:Patient Participation; D018579:Patient Selection; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D012170:Retinal Vein Occlusion / Q000188:drug therapy*; D012189:Retrospective Studies; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D000068258:Bevacizumab; D040262:Receptors, Vascular Endothelial Growth Factor