MERIT Ophthalmology Case Studies
No matter the phase of your project, from pilot study to large Phase III multi-center trial, MERIT provides the medical expertise, operational experience, technology platform, and quality assurance to help you achieve your development goals. MERIT’s comprehensive portfolio of ophthalmic services ensures your research is conducted accurately and efficiently. We seamlessly manage the imaging components of your trial, creating efficiencies for your drug development. To learn more about MERIT’s ophthalmology solutions, read our case studies below.
CASE STUDY 1: REDUCING IMAGING OUTLIERS THROUGH TRAINING AND EXCELSIORTM
A large global biopharmaceutical company conducted a pilot study to establish a standardized and extensible procedure for retinal image acquisition in conjunction with laboratory assessments and blood pressure measurements. Once established, the methodology was to be implemented in a larger study to support the development of a machine-learning algorithm for prediction of vital sign measurements, laboratory findings, and diabetic and cardiovascular disease states based on digital retinal images.
The study was conducted at 2 sites in Africa with a planned enrollment of 300 subjects. The methodology was developed based on images from a large-scale biomedical database in Europe. Thus, a key study goal was to confirm if the algorithm would have a comparable level of accuracy in an African population. It was also planned to test the feasibility of obtaining analyzable retinal images in a more limited healthcare facility setting.
RESULTS AND HIGHLIGHTS
- Few imaging issues due to training. Very few imaging issues arose during the study due to careful planning and extensive training
- No data loss. No data lost due to image quality issues
- High quality images. High quality Images were key to the study’s success and formed the basis for testing the AI algorithm
- Quick indexing for AI training. Standard image file naming schema allows data to be quickly indexed and used as a training dataset for future AI algorithms
CASE STUDY 2: COMPLEX OPHTHALMIC IMAGING SOLUTIONS
A large global biotechnology company sponsored a phase III trial at multiple global sites to evaluate the efficacy and safety of a new Vascular Endothelial Growth Factor (VEGF) antagonist administered via intravitreal injection in subjects with neovascular age-related macular degeneration (nAMD). This study required approximately 500 subjects to complete up to 26 monthly visits over two years.
RESULTS AND HIGHLIGHTS
- Rapid Turnaround Time: Efficient, quick turnaround times for image processing and grading, including 48-hour turnaround for eligibility. On average, the results of the eligibility visits were determined within 6 hours
- Complex Coordination of Services, Equipment, and Imaging Modalities: MERIT successfully managed multiple Reading Centers, harmonized imaging data from many manufacturers, and evaluated various imaging modalities
- Volume of Data Series: There were 82,448 total data series processed and reviewed for this study. MERIT ensured thorough and punctual quality control, enabling the partner Reading Center to quickly grade per the trial protocol