New objective endpoints enable better-focused, shorter trials on neuroprotective agents

NICE, France — Advances in optical coherence tomography may help establish new, objective endpoints for clinical trials of neuroprotective agents as glaucoma therapies, according to one specialist.

“New-generation OCT technology allows us to visualize the optic nerve where it enters the globe and the Bruch’s membrane finishes. This means we have an objective measure as opposed to subjective evaluation of the edges of the optic disc,” M. Francesca Cordeiro, MD, said at the 2014 European Glaucoma Society meeting.

OCT contour maps also allow evaluation of the retinal nerve fiber layer thickness, where areas of thinning can be detected as a sign of glaucomatous damage.

“There is also our own technology for detection of apoptosis of retinal cells, which we believe really highlights early activity and picks up by visualization which retinal cells are dying through this process,” Cordeiro said.

These new means will enable earlier, objective detection of functional damage in glaucoma and will help establish new endpoints for better-targeted, shorter neuroprotection trials, according to Cordeiro.

Thus far, only two neuroprotective agents have reached the clinical trial stage. Memantine was the first, but study progress was hindered by problems related to the large, heterogeneous population recruited. The other agent, brimonidine, was tested in normal tension glaucoma.

“There are a number of drawbacks that people highlighted with that trial, but it remains the only published clinical trial where a positive effect of neuroprotection in stopping visual field progression occurred by an agent acting through a non-IOP dependent mechanism,” Cordeiro said.

Disclosure: Cordeiro holds the patent for DARC imaging and is a consultant for Allergan, Alcon, and Théa.