Trends in Ophthalmology Clinical Trials

November 1, 2018

By Angela Woodall, Healthcare and Environmental Reporter.

From simple cell forms, the eye matures and develops into one of the most intricate sensory organs, capable of detecting, converting, and interpreting light signals, an exquisitely complex feat. How this happens involves genetic and cellular factors that interact with and regulate each other.

The origins of ophthalmology, which occupies itself with these processes when they go awry, reaches back to the earliest recorded history, although it would take thousands of years to develop a working model of the eye’s structure and function. Today’s techniques and tools have incorporated those early lessons and built on them with generations of research and trials.

Until recently, progress has been defined by increasingly sophisticated techniques but with relatively few breakthroughs in the most common eye disorders — retina, glaucoma and macular degeneration. Based on numbers alone, these three areas of research dominate ophthalmic clinical trials: Retina (691 trials), Glaucoma (229 trials), and Macular Degeneration (331 trials).

Changes in ophthalmology research are paralleled in other fields. However, clinical trials in the human eye are different from most studies, beginning with the fact that the subject of investigation and treatment come in pairs: If a condition affects both eyes, only one eye is placed in a treatment group, randomly assigned, for a study while the other may be in the control group. Optic nerves, unlike damaged peripheral nerves, cannot regenerate after surgery. As a result, vision loss due to diseases can be permanent, adding to the urgency with which researchers, patients and their advocates are pursuing multiple approaches.

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This document covers the following topics:

• Regenerative treatments are on the threshold of moving from safety to efficiency testing.
• Outcome measures in trials can play a significant role in moving regenerative medicine forward.
• Stem cell techniques are important pathways to addressing the underlying causes of glaucoma.
• Cannabinoids have potential to become more mainstream in a range of eye pathology treatments.
• Gene testing will increase the efficacy of trials by identifying patients responsive to treatments.
• CRISPR/Cas9 gene-editing technology is still several years away from moving out of the lab.
• Imaging techniques are of growing importance to here-and-now ophthalmology clinical trials.
• Public-private partnerships will play a transformative role in the near term.
• Successful clinical trial designs must have a team approach funding from multiple sources.
• Effective teams will include scientists, clinicians, manufacturing experts and regulators.

 

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