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Glaucoma is an eye condition characterized by increased intraocular pressure that damages the retina and optic nerve, leading to irreversible blindness if left untreated. The human eye has various components, including the cornea, iris, pupil, lens, and optic nerve. Aqueous humor is secreted by the epithelium of the ciliary body in the posterior chamber and flows through the trabecular meshwork and canal of Schlemm, maintaining normal intraocular pressure. The trabecular meshwork and the canal...

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Related Experiment Video

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Full-Circle Cauterization of Limbal Vascular Plexus for Surgically Induced Glaucoma in Rodents

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Biomarkers and Surrogate Endpoints: Lessons Learned From Glaucoma.

Felipe A Medeiros¹

¹Hamilton Glaucoma Center, Department of Ophthalmology, University of California San Diego, La Jolla, California, United States.

Investigative Ophthalmology & Visual Science

|May 6, 2017

Summary

Glaucoma clinical trials need validated surrogate endpoints. Current imaging and intraocular pressure (IOP) measurements lack sufficient evidence for predicting treatment success on vision outcomes.

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Area of Science:

Ophthalmology
Clinical Trials
Biomarker Research

Background:

Recent advancements in glaucoma imaging technologies have spurred debate on their use as surrogate endpoints in clinical trials.
Surrogate endpoints in clinical trials require rigorous validation based on established medical and regulatory standards.

Purpose of the Study:

To review the criteria for valid surrogacy in glaucoma clinical trials.
To critically evaluate intraocular pressure (IOP) and imaging measurements as potential surrogate endpoints for clinically relevant outcomes in glaucoma.

Main Methods:

Review of existing literature on surrogate endpoint validation in medicine.
Analysis of the predictive value of IOP and imaging biomarkers for functional outcomes in glaucoma.
Assessment of regulatory requirements for surrogate endpoints.

Main Results:

Intraocular pressure (IOP) lacks proper validation as a surrogate endpoint for IOP-lowering treatments despite its common use.
Imaging measurements show promise as predictors of functional outcomes but lack sufficient evidence for use as standalone surrogate endpoints.
Composite endpoints incorporating imaging biomarkers may overcome limitations of isolated structural or functional measures.

Conclusions:

Further research and well-designed studies are necessary to validate potential biomarkers for glaucoma clinical trials.
Current imaging and IOP measurements require more evidence to serve as reliable surrogate endpoints for predicting long-term visual function and quality of life in glaucoma patients.