NCT02128113

RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.

Detailed description

Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells, and may be a factor resulting in the acute decrease in corneal endothelial cell density following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and chronic inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate IOP and induce cataract formation. In addition, most available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects. This study will assess the safety and efficacy of omaveloxolone (RTA 408) Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.

Conditions

• Corneal Endothelial Cell Loss
• Ocular Pain
• Ocular Inflammation
• Cataract Surgery

Interventions

Type	Name	Description
DRUG	Vehicle Ophthalmic Solution	Opthalmic suspension manufactured to mimic RTA 408 suspension
DRUG	Omaveloxolone Ophthalmic Suspension 0.5%	0.5% ophthalmic suspension of RTA 408
DRUG	Omaveloxolone Ophthalmic Suspension 1%	1% ophthalmic suspension of RTA 408

Timeline

• Start date: 2014-05-31
• Primary completion: 2015-02-28
• Completion: 2015-04-30
• First posted: 2014-05-01
• Last updated: 2025-06-03
• Results posted: 2023-05-26

Locations

15 sites across 1 country: United States