Doheny Image Reading Center
What is the Doheny Image Reading Center?
The Doheny Image Reading Center (DIRC) leads the way in supporting clinical trials and researchers with the identification, characterization and quantification of ophthalmic imaging endpoints. DIRC uses both traditional imaging techniques as well as the latest imaging technologies to evaluate these endpoints in support of clinical trials and research that ranges from natural history studies all the way to phase 3 registration clinical trials.
DIRC’s Quality Policy:
DIRC provides high quality ophthalmic image interpretations to the clinical and research fields and is committed to being in compliance with current regulatory requirements and industry standards and to continuous improvement.
Established at Doheny Eye Institute in 2003 under the direction of SriniVas Sadda, MD, DIRC has served as the centralized reading center for a large number of clinical trials spanning a variety of diseases, such as age-related macular degeneration, choroidal neovascularization, geographic atrophy, diabetic retinopathy, retinal vein occlusion, vitreomacular interface disease, retinal detachment, inherited retinal diseases, peripheral retinal degenerations, Stargardt disease, and choroideremia.
Dr. Sadda, who now serves as DIRC’s Emeritus Medical Director, was formerly an investigator at the Wilmer Reading Center and has supervised the grading of images for large-scale clinical trials, including photodynamic therapy studies and the Submacular Surgery Trial. Dr. Sadda’s expertise and interest in establishing worldwide standards in ophthalmic eye care have allowed DIRC to establish itself as a driving force in retina research.
Today, Michael Ip, MD, serves as DIRC’s Medical Director. Dr. Ip joined Doheny in June 2016. He was previously at the University of Wisconsin at Madison, where he served on the faculty and as a co-director of the Fundus Photograph Reading Center. At both, the Fundus Photograph Reading Center and DIRC, Dr. Ip has been involved with assisting in the design, endpoint selection, image analysis and data interpretation for numerous ophthalmic clinical trials.
Through its distinguished investigators, DIRC has been able to make major progress and breakthroughs in this area of ophthalmic research, making DIRC a well-rounded, comprehensive, and full-service center. New research areas and ongoing clinical trials support beyond retinal disease to glaucoma, anterior chamber, cornea and ocular surface/tear film.
To assist sponsors of clinical research and clinical research organizations, DIRC provides a number of services:
- Part 11 compliant automated workflow system with web-based portals for image receipt and electronic results transfer
- Assistance with clinical protocol development
- Standardized imaging protocols
- Photographer and imager qualification, training, and performance feedback
- Grading protocol applications
- Instructions for documenting and transmitting images
- Monitors received images in real-time and provides status reports
- Image assessment by trained and certified graders applying a standard grading protocol
- Selection of a variety of reporting options
- Data backup procedures and disaster recovery plans
- Secure long-term archiving of study materials, both digital and hardcopy
- Input and assistance with advisory board meetings, scientific manuscripts, and related efforts
Why Use DIRC?
The Doheny Image Reading Center continues to play a critical role in clinical trials in ophthalmology, spanning all areas of ophthalmic research. Through a dedicated and highly-qualified team of researchers, clinicians, graders, and staff, DIRC leads the way in supporting researchers in the characterization and quantification of ophthalmic disease. In addition to carefully developed training and grading protocols and procedures that meet or exceed prevailing regulatory standards, DIRC’s leading role in supporting research is due to its dedication to continuous quality improvement leading to a series of initiatives.
The DIRC provides:
- Grading excellence, exceeding industry standards.
- Hands-on involvement of DIRC investigators in all phases of study execution and with final responsibility for all study data.
- Excellence in client service, with accessibility, responsiveness, and customization.
- Proprietary and innovative advanced software (GRADOR & OCTOR) to facilitate the image reading process.
- Quantitative sub-analysis of OCT images, allowing us to produce highly accurate measurements of retinal abnormalities.
- Highly detailed lesion analysis for multi-component lesions studied by fluorescein angiography.
- Quantitative and qualitative analysis of the corneal endothelium through FDA-approved specular microscopy grading methods.
- Compliance with applicable regulations:
- Title 21 of Code of Federal Regulations (21 CFR) Parts 11, 312, 812
- Title 45 of Code of Federal Regulations (45 CFR) Parts 160, 164
- International Council on Harmonization (ICH) E6 “Good Clinical Practice”
- Good Automation Manufacturing Practice (GAMP5)
- General Data Protection Regulation (GDPR)