Related Experiment Video
Updated: May 22, 2026
10:38
Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
Clinical endpoints special session, ISCEV 2025, Utrecht
R Hamilton1,2, D Birch3, K Stingl4
1Department of Clinical Physics & Bioengineering, Royal Hospital for Children, Glasgow, UK.
Documenta Ophthalmologica. Advances in Ophthalmology
|May 20, 2026
Summary
Clinical endpoint evaluation for inherited retinal disorders (IRDs) needs improvement. Discussions emphasized anchoring new endpoints to meaningful outcomes and reducing patient assessment burdens for better trial efficiency.
Area of Science:
- Ophthalmology
- Clinical Trials
- Genetics
Background:
- Inherited retinal disorders (IRDs) present challenges in clinical trial endpoint selection.
- The International Society for Clinical Electrophysiology of Vision (ISCEV) convened a special session to address these challenges.
Purpose of the Study:
- To summarize discussions on the current state and future directions of clinical endpoints in IRD trials.
- To identify key challenges and propose solutions for endpoint development and implementation.
Main Methods:
- A summary of a special session at the 62nd ISCEV annual symposium.
- Involved clinicians, regulators, industry, and patients in discussions.
Main Results:
- Current endpoints may not be fully adequate for the heterogeneity of IRDs.
- Disease heterogeneity, regulatory expectations, and operational feasibility pose significant challenges.
- Patient perspectives are crucial for endpoint development.
Conclusions:
- Emerging endpoints must be validated against clinically meaningful outcomes.
- Minimizing the assessment burden on patients is essential for trial success.
- Collaboration among stakeholders is vital for advancing IRD clinical trials.
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