drugset / Trial / NCT02390284

Stop Retinal Ganglion Cell Dysfunction Study

NCT02390284

RandomizedParallel-groupOpen-labelPrevention

Summary

Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease, predicting its severity and the benefit of pressure lowering eye drops is key to clinical management aimed at maintaining useful vision with advancing age. This study will longitudinally monitor a population of glaucoma suspects (with positive factors for the disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG will be left untreated. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests every 6 months over 4 years.

Timeline

Start
2015-09
Primary completion
2024-10-04
Completion
2024-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetazolamide Small molecule Other
Subject Bimatoprost Other / unclassified Other
Subject Brinzolamide Small molecule Other
Subject Dorzolamide Small molecule Other
Subject Latanoprost Small molecule Other
Subject Methazolamide Small molecule Other
Subject Timolol Other / unclassified Other
Subject Travoprost Other / unclassified Other

Indications