Given the emergence of Optical Coherence Tomography (OCT) imaging as the preferred method of documenting the retinal morphology of AMD and DME, clinical trial protocols must include OCT imaging endpoints as a critical requirement of the testing regimen. Efficacy of a proposed biosimilar drug is judged by its ability to decrease the abnormal fluid into and under the retina, as evidenced by degree of retinal thickening measured on OCT images.
OCT technology provides objective measurement of retinal thickening in the macular region. However, for the resultant data to be considered reliable, and to be incorporated into a regulatory submission, several technical challenges must be overcome. Three key challenges are outlined below.
(1) Achieving Usable Quality in OCT Scans
Ophthalmology clinics that can be recruited as clinical trial centers are equipped with a variety of disparate OCT scanners operated by technicians with wide range of competence and experience. Usable, high quality scans are not a given.
(2) Receiving Scans from Different OCT Models into a Common Analysis Environment
Different OCT scanner manufacturers feature different data formats and different internal tools for analyzing scans. Getting all scans into a unified format requires deep familiarity with industry standards and robust centralized software for uploading.
(3) Keeping Track of Whether Acceptable Scans are Being Submitted
Busy clinical centers can lag in submitting the periodic scans required from study patients, and sometimes make mistakes in identifying information. Sponsors conducting scheduled analyses are hampered when the expected results are late or not available.
MERIT provides key Contract Research Organization services that facilitate the gathering, analysis, interpretation, and presentation of ocular morphology data, notably OCT imaging results, in animal studies, clinical trials and regulatory submissions.
To read about MERIT’s solutions for these challenges, download our white paper Testing Biosimilar Drugs for Regulatory Approval: The MERIT Advantage.