Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
Status:
Completed
Trial end date:
2018-06-30
Target enrollment:
Participant gender:
Summary
Phase 2, open-label, randomized, multi-center studies in infants and premature infants are
necessary to determine treatment and preventative strategies for ROP. This study was designed
to: a) target infants at the highest risk of ROP in a large number of centers with variable
rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus
systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study
is designed to determine whether the novel treatment regimens are safe and potentially
effective for ROP prevention and to obtain requisite data for the development of a Phase III
efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as
standard of care for ELGANs, no placebo group is included.
Phase:
Phase 2
Details
Lead Sponsor:
State University of New York - Downstate Medical Center
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Food and Drug Administration (FDA)