Learn how high-quality retinal images were key to this pilot study’s success and formed the basis for testing an AI algorithm....
Therapeutic Expertise: Ophthalmology
MERIT is an ophthalmology reading center supporting Phase I – IV clinical trials. Our team are experts in managing and evaluating images, especially with ocular diseases affecting the retina. As a trusted partner to sponsors and CROs, we provide domain expertise, innovative imaging tools, and scalable solutions.
With MERIT, you benefit
from the following:
- High-quality, reliable data review and interpretation: MERIT’s team of knowledgeable ophthalmologists (several are board-certified) provide domain expertise to assure high-quality, consistent data review and interpretation
- Innovative Comprehensive Data Platform: Our cloud-based EXCELSIOR™ platform allows immediate transfer of data directly from qualified sites to a central database for review without installing software or configuring firewalls
- Competitive Pricing and Shortened Timelines: Sponsors benefit by gaining efficiencies due to our refined and standardized processes.
With MERIT, your ophthalmology study data and images can easily be shared between clinical sites, reading centers, CROs, and sponsors for maximum transparency. This makes managing global ophthalmic trials involving multiple reading centers and analysis of multiple modalities not only feasible, but practical.
OUR OPHTHALMIC PROCESS
Messages are sent directly to the project team from our data acquisition platform, allowing for smoother tracking of images
Our data acquisition platform makes site queries more efficient.
Immediate quality control enables quick confirmation that images have been acquired correctly
Prompt feedback to the site prevents further images from being acquired incorrectly
OPHTHALMOLOGY IMAGING SERVICES
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.
OUR IMAGING SERVICES:
- Protocol Design & Consultation
- Site Certification
- Image Acquisition & Upload
- Image Read & Adjudication
- Imaging Site Support
- Study Management
- Quality Assurance
IMAGING MODALITIES:
BCVA Services
Full, Abbreviated, and Express Certifications for VA Examiners
Full and Express Certifications for VA Rooms
Certificates Maintained in EXCELSIORTM
Confirmation of Acceptable BCVA Equipment
Scheduling, Tracking & Reporting of BCVA Certification Study Activities
Visual Acuity Certifications: ETDRS, Low Luminance, Contrast Sensitivity & Reading Assessments
VA Room Equipment Procurement
Endothelial Cell Count (ECC) Analysis
MERIT provides ECC services for the following ocular clinical trials:
- Corneal dystrophies, corneal edemas, keratoconus, etc.
- Cataract surgery
- Intraocular Lens (IOL) implants
- Safety assessment for intravitreal injection (nAMD, DME)
- Safety assessment for ocular implants (Glaucoma)
- Safety assessment for eyedrops (dry eye disease, etc.)
OPHTHALMOLOGY EXPERTISE
Adept analysis and proven expertise with MERIT.
A successful multi-center trial requires intrinsic understanding of various imaging techniques, developing meaningful outcome correlations, and formulating computational methodologies. Our insightful experts (several are board-certified ophthalmologists) help guide your selection of the right biomarkers that accurately reflect the characteristics of disease progression and treatment effects.
EXPERIENCE BY THE NUMBERS
OPHTHALMOLOGY STUDIES BY INDICATION
OPHTHALMIC CASE STUDIES
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IMAGING SOFTWARE
MERIT’s cloud-based EXCELSIOR™ platform allows immediate transfer of data directly from qualified sites to a central database for review without installing software or configuring firewalls. Our exceptional reading center services for ophthalmic imaging can be easily configured to meet sponsor and study requirements. EXCELSIOR, built specifically for supporting image data collection and management for ophthalmic clinical trials, offers the latest web and imaging technologies for data standardization, analysis, grading, and reporting.
OPHTHALMOLOGY DISEASE STATES
AMD
Age Related Macular Degeneration (AMD) is a common eye condition and leading cause of vision loss among people aged 50 and over.
UVEITIS
Uveitis refers to the inflammation of structures on the uveal tract and causes 10-15% of cases of legal blindness in the US.
DR/DME
Diabetic Retinopathy/Diabetic Macular Edema (DR/DME) is the most common cause of vision loss among people with diabetes and a leading cause of vision impairment/blindness among working-age adults. Chronically high blood sugar is associated with damage to the blood vessels in the retina.
RVO
Retinal Vein Occlusion (RVO) is a common vascular disorder of the retina and one of the most common causes of vision loss worldwide.
INHERITED RETINAL DISEASES
Therapeutic options are under investigation for the treatment of previously untreatable Rare or Orphan diseases in ophthalmology such as Retinitis Pigmentosa, Usher Syndrome, Stargardt Disease and Leber Congenital Amaurosis.
MERIT Ophthalmology Imaging Solutions Guide
MERIT Reading Center Services Solutions Guide