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

NCT ID: NCT02128113

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Vehicle Ophthalmic Solution

A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

Group Type: PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type: DRUG

Opthalmic suspension manufactured to mimic RTA 408 suspension

Omaveloxolone Opthalmic Suspension 0.5%

A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

Group Type: EXPERIMENTAL

Omaveloxolone Ophthalmic Suspension 0.5%

Intervention Type: DRUG

0.5% ophthalmic suspension of RTA 408

Omaveloxolone Opthalmic Suspension 1%

A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

Group Type: EXPERIMENTAL

Omaveloxolone Ophthalmic Suspension 1%

Intervention Type: DRUG

1% ophthalmic suspension of RTA 408

Interventions

Vehicle Ophthalmic Solution

Opthalmic suspension manufactured to mimic RTA 408 suspension

Intervention Type: DRUG

Omaveloxolone Ophthalmic Suspension 0.5%

0.5% ophthalmic suspension of RTA 408

Intervention Type: DRUG

Omaveloxolone Ophthalmic Suspension 1%

1% ophthalmic suspension of RTA 408

Intervention Type: DRUG

Other Intervention Names

RTA 408 Ophthalmic Suspension 0.5%; RTA 408 Ophthalmic Suspension 1%

Eligibility Criteria

Inclusion Criteria

1. Be male or female and ≥18 years of age and ≤80 years of age

2. Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens

3. Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery

4. Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III

5. Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy

6. Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit

7. Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria

1. Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye

2. Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface

3. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing

4. Have an intraocular pressure (IOP) ≤5 mmHg in either eye

5. Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye

6. Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harvard Eye Associates

Laguna Hills, California, United States

Hull Eye Center

Lancaster, California, United States

Argus Research

Cape Coral, Florida, United States

Levenson Eye Associates

Jacksonville, Florida, United States

Chicago Cornea Consultants

Hoffman Estates, Illinois, United States

JacksonEye

Lake Villa, Illinois, United States

Discover Vision Centers

Leawood, Kansas, United States

Opthalmic Consultants of Boston

Waltham, Massachusetts, United States

Talamo Hatch Laser Eye Consultants

Waltham, Massachusetts, United States

Associated Eye Care

Stillwater, Minnesota, United States

Comprehensive Eye Care

Washington, Missouri, United States

Alterman, Modi and Wolter

Poughkeepsie, New York, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

R & R Eye Research

San Antonio, Texas, United States

See Clearly Vision Group

McLean, Virginia, United States

Countries

United States

Other Identifiers

RTA 408-C-1309

Identifier Type: -

Identifier Source: org_study_id