Investigator Initiated Trial to evaluate a novel Glaucoma Drainage Implant (GORE GDI) in Subjects with Primary Open-Angle Glaucoma

Glaucoma is the leading cause of irreversible blindness in the world. In a recent review in the Indian Journal of Ophthalmology, it was found that epidemiological studies on glaucoma involving Indian adults aged 40 years and above have an estimated glaucoma prevalence between 2.7 and 4.3%.  Glaucoma is responsible for blindness in 1.2 million people and accounts for 5.5% of total blindness in India.

The reduction of intraocular pressure (IOP) is currently the only known modifiable risk factor that has been shown through large randomized controlled clinical trials to reduce both the risk of developing glaucoma and the progression of existing disease.  For the subset of the glaucoma patient population that is unresponsive to medical therapy, surgical intervention is needed to safely and effectively manage intraocular pressure.  Glaucoma drainage implants are commonly used to treat patients with primary open-angle glaucoma where conventional surgical treatments have not been successful to control disease progression and patients with primary open-angle glaucoma that is uncontrolled by hypotensive medications. All of the currently available devices have a similar design where a small diameter silicone tube is inserted into the anterior chamber to drain aqueous humor to an episcleral plate. Unfortunately, these devices fail at about 10% per year, resulting in about 50% failure at 5 years due to fiberous encapsulation of the plate decreasing the permeability of the tissues to aqueous leading to an increase in IOP.

This study intends to evaluate the safety of a non-valved, drainage device that shunts aqueous fluid via a silicone tube to an episcleral reservoir that is comprised of the proprietary Gore material expanded polytetrafluoroethylene (ePTFE).  The material is known to be biocompatible and associated with reduced inflammation and scarring response.

GORE has initiated a clinical trial in the Dominican Republic to evaluate the GORE GDI, ClinicalTrials.gov identifier: NCT05557058, but has not completed enrollment.  To date, the device has been well tolerated and there have been no serious adverse events reported.   While the device has been implanted and used to treat primary open angle glaucoma, the healing response and performance of the device in the Indian population may differ from the performance observed in the Dominican Republic patient population.  These differences require evaluation to ensure the device is safe and effective.