In today’s funding environment, sponsors cannot afford preventable rework on ocular endpoints. Regulators are closely examining a potential link between GLP-1 receptor agonists and non-arteritic anterior ischemic optic neuropathy (NAION).
Recent epidemiological data
show semaglutide exposure doubles NAION risk (hazard ratio 2.19), though absolute risk remains low—about one extra case per 10,000 person-years.
In June 2025, the European Medicines Agency’s PRAC concluded NAION is a “very rare” side effect of semaglutide and updated product labels accordingly. Sponsors should expect heightened scrutiny of GLP-1 ocular safety monitoring plans and study records.
What Is Needed for GLP-1 Ocular Safety Monitoring
- Enhanced Screening Procedures
Implement protocol-appropriate baseline and periodic comprehensive eye exams (BCVA, anterior and posterior segment ocular health assessments, fundus imaging, OCT when indicated) to establish ocular health status before and during treatment.
- Rapid Adverse-Event Detection
Define and document clear workflows for immediate evaluation when participants report sudden vision changes, enabling real-time identification and management of NAION signals.
- Audit-Ready Documentation
Maintain standardized device calibration logs, QC-approved source documentation, technician competency records, deviation logs, and visit-level checklists mapped to protocol requirements.
How 20/20 Onsite Operationalizes GLP-1 Ocular Safety Monitoring
20/20 Onsite delivers standardized ophthalmic assessments at the point of need—on-site, near patients, or in community settings—so you capture protocol-compliant data on the first attempt and keep your audit file inspection-ready.
- Standardized Equipment
Locked device models/firmware for OCT and fundus cameras, with daily calibration and auditable logs.
- Certified Personnel
Ophthalmic technicians and physicians trained on study-specific procedures (e.g., BCVA, OCT Imaging, Fundus Photography) operating under sponsor/CRO SOPs.
- Centralized Oversight & Documentation
Documentation tracks first-time-right rate, retake metrics, and query counts. All calibration certificates, training records, and logs are stored in an inspection-ready audit repository.
Key Benefits
- Reduces variability across multi-site programs with identical devices, settings, and workflows.
- Cuts avoidable rework by catching QC flags while participants are still on-site.
- Keeps ocular endpoint files continuously inspection-ready, not just before audits.
Why Now?
- EMA PRAC has updated semaglutide product information to include NAION as a very rare side effect.
- Post-marketing surveillance and real-world evidence initiatives highlight the need for proactive ocular safety monitoring.
A Practical Path You Can Start This Month
- Ocular Endpoint Risk Scan
Map your schedule of assessments to operational risks by visit and modality; confirm device specs, calibration plan, and training requirements.
- Activation
Stage calibrated equipment, finalize SOP alignment, run mock visits, validate data flows, and activate live-QC dashboards (first-time-right, retake rate, query rate).
- Steady-State Operations & Reporting
Deploy mobile capacity as needed, maintain daily calibration and live QC, and keep an organized, monitor-friendly audit file.
Talk to Our Team (No Obligation)
Planning or running a GLP-1 study with ocular endpoints? Schedule a 30-minute consultation to review your protocol and site footprint. We’ll deliver a focused risk map (devices, training, QC, documentation) and a right-sized deployment option to strengthen your GLP-1 ocular safety monitoring.
Schedule Your Consultation → Understand Your Risk