What is the Doheny Image Reading Center?
The Doheny Image Reading Center (DIRC) leads the way in supporting clinical researchers in the characterization and quantification of ophthalmic disease, with ever greater reliability. Using the latest imaging technology and employing standardized approaches to retinal image grading, DIRC provides new opportunities to use clinical imaging outcomes in the study and validation of new treatments.
Among the goals of the Reading Center are the generation of useful and correlative data to demonstrate the safety and efficacy of potential new treatments and the validation of non-invasive imaging techniques in the monitoring and management of ophthalmic diseases.
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, vein occlusions, macular ischemia, vitreomacular interface disease, retinal detachment, hereditary macular degeneration, peripheral retinal degeneration, stargardts, and choroideremia.
Dr. Sadda, who now serves as the DIRC 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 research interests have allowed DIRC to establish itself as a driving force in retina research.
In June 2016, Dr. Michael Ip, MD, joined DIRC as Medical Director. Dr. Ip joins Doheny from the University of Wisconsin at Madison, where he served as a member of the faculty since 1999. Most recently, he held the position of co-director at the Fundus Photograph Reading Center within the Department of Ophthalmology and Visual Sciences. Dr. Ip has also participated in numerous clinical trials throughout his career, including his role as the national principal investigator of the Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study and the national co-principal investigator of the SCORE2 Study.
Through our distinguished investigators, our center has been able to make major progress and breakthroughs in this area of ophthalmic research as well, making DIRC a well-rounded, comprehensive ophthalmic research center. New research areas and ongoing clinical trial support now include 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 portalsfor image receipt and electronic results transfer.
- Assists with clinical protocol development
- Develops and provides standardized photography protocols
- Provides photographer qualification, training, and performance feedback
- Applies appropriate grading protocols
- Instructs in methods for documenting and transmitting images
- Monitors received images in real-time and provides status reports
- Provides image assessment by trained, certified graders applying a standard grading protocol
- Provides a variety of reporting options
- Provides data backup procedures and a disaster recovery plan
- Provides secure long-term archiving of study materials, both digital and hardcopy
- Provides 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 clinical researchers in the characterization and quantification of ophthalmic disease, with ever greater reliability. In addition to carefully developed training and grading protocols and procedures that meet or exceed prevailing regulatory standards, DIRC’s leading role in supporting clinical researchers has been possible thanks to our own efforts to go above and beyond what is currently available on the market through 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)