Michael Yang, MD
Site principal investigator since 2015,
Michael Yang, MD, works with colleagues from the Pediatric Eye Disease Investigator Group (PEDIG). The design of the phase 1 study dose de-escalation study is to find the lowest effective dose of intravitreal bevacizumab, an anti-vascular endothelial growth factor (VEGF) antibody, for the treatment of severe retinopathy of prematurity (ROP), since the previously used standard dose of 0.625 mg was likely excessively high and decreasing the systemic exposure of the infant to the injected bevacizumab was likely important to minimize risk. In the first part of the ROP1, the study, previously published in
JAMA Ophthalmology in 2017, found a dose of bevacizumab as low as 0.031 mg (5% of the previously accepted standard dose) to be effective. This prompted the addition of four additional levels of dose reductions in the study down to the lowest dose of 0.002 mg (<0.5% of the original standard dose) for the second part of the study. The completion of the additional dose level reductions is recent, and analyzation of the results is in process before submission for publication. Because the number of patients at each dosing level was necessarily small, the findings will be important in the design of additional studies involving larger numbers of premature infants for comparison of dosing levels or comparison with other modalities of treatment (such as a different anti-VEGF medication or laser photocoagulation therapy). Dr. Yang,
Michael Gray, MD, and
Eniolami Dosunmu, MD, were significant contributors of treated patients, while
Walker Motley, MD, MD;
Terry Schwartz, MD; and Brenda Connors, MD, all served as co-investigators or certified examiners in the study.
Michael Gray, MD
Dr. Gray is the site principal investigator for most of the clinical studies that Cincinnati Children's participates in as part of PEDIG. This multinational network facilitates multicenter clinical research in strabismus, amblyopia, and other eye disorders of children. Since 2012, our site is among the top recruiters for several studies. Currently we are recruiting for the Amblyopia Treatment Study 20 (ATS20), a unique binocular approach to treating amblyopia in children using a game on an iPad. We will soon complete the Intermittent Exotropia Study 5 (IXT5), a randomized trial of overminus glasses therapy for intermittent exotropia. The design of the trial was to evaluate the longer term effectiveness of overminus glasses for intermittent exotropia following the positive results seen from an earlier study (IXT3). We were among the top recruiting sites in that study. Published results appeared in Ophthalmology with Dr. Gray as a co-author. In addition to recruiting for these studies, Dr. Gray participated in several planning committees for PEDIG, including a soon-to-be launched study examining prism glasses for intermittent exotropia and a future amblyopia study using occlusion dose monitors.
Melissa Rice, MD
Melissa Rice, OD, FAAO, recently completed a retrospective analysis on 198 children diagnosed with cortical or cerebral visual impairment (CVI) at Cincinnati Children's within the
Division of Ophthalmology from January 1, 2008 through March 1, 2018. These visits resulted in four abstracts presented at two international meetings. Multiple research questions investigated produced significant findings including: children with higher CVI range score (meaning less severe CVI) were more likely prescribed glasses compared to those with lower CVI range scores (meaning more severe CVI), the time between the first visit to the division and CVI diagnosis was 1.1 years, on average patients with CVI received a diagnosis at their third visit, children with less severe CVI took longer to diagnose, premature CVI patients had higher CVI range scores compared to full term CVI patients, and accommodative insufficiency was more prevalent in CVI patients with cerebral palsy taking anti-epileptic drugs. This research led to a CVI collaboration with a neuroscientist researcher at Schepens Eye Research Institute at Massachusetts Eye and Ear in Boston, MA investigating MRI findings. Our research team, which includes Dr. Schwartz, is currently drafting multiple papers to publish the findings. Next steps for this research include designing a prospective CVI study to identify children seen in our clinic with undiagnosed CVI, as well as developing a CVI registry to ensure that proper referrals and follow up intervals are being ordered by physicians at time of diagnosis.
Terry Schwartz, MD
Karen Harpster, PhD, OTR/L, in the
Divisions of Occupational Therapy and Physical Therapy, collaborated on a project completed and presented at the Children’s Vision Research Society in Pisa Italy in June 2019. The research received funding by the Maxon Foundation with the objective of increasing access to intervention for child with cerebral visual impairment using a telemedicine based approach. They are currently working on a retrospective chart review of all children identified with cerebral visual impairment. Drs. Harpster and Schwartz submitted a grant in collaboration with Dr. Corinna Bauer from Massachusetts Eye and Ear to include review of imaging data as part of this effort.
