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

NCT02128113 | Completed Phase 2 Results

• 1 other identifier: RTA 408-C-1309
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 15

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.

Conditions

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

Keywords

RTA 408; Cataract surgery; Corneal Endothelial Cells; omaveloxolone

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Central Corneal Endothelial Cell Counts

  Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline

  12 weeks

Secondary Outcomes (5)

• Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery

  2 weeks

• Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery

  2 weeks

• Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery

  2 weeks

• Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery

  1 day

• Change From Baseline in Central Corneal Endothelial Cell Counts

  6 weeks

Study Arms (3)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

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

Drug: Vehicle Ophthalmic Solution

Omaveloxolone Opthalmic Suspension 0.5%

EXPERIMENTAL

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

Drug: Omaveloxolone Ophthalmic Suspension 0.5%

Omaveloxolone Opthalmic Suspension 1%

EXPERIMENTAL

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

Drug: Omaveloxolone Ophthalmic Suspension 1%

Interventions

Vehicle Ophthalmic Solution DRUG

Opthalmic suspension manufactured to mimic RTA 408 suspension

Vehicle Ophthalmic Solution

Omaveloxolone Ophthalmic Suspension 0.5% DRUG

0.5% ophthalmic suspension of RTA 408

Also known as: RTA 408 Ophthalmic Suspension 0.5%

Omaveloxolone Opthalmic Suspension 0.5%

Omaveloxolone Ophthalmic Suspension 1% DRUG

1% ophthalmic suspension of RTA 408

Also known as: RTA 408 Ophthalmic Suspension 1%

Omaveloxolone Opthalmic Suspension 1%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be male or female and ≥18 years of age and ≤80 years of age
• Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
• Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
• Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
• Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
• Have endothelial cell density of \>1800 cells/mm2 in the study eye at the Screening Visit
• 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

You may not qualify if:

• Have a score \>0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
• Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
• Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
• Have an intraocular pressure (IOP) ≤5 mmHg in either eye
• 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
• 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

Sponsors & Collaborators

• Biogen: lead
• AbbVie: collaborator

Study Sites (15)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Hull Eye Center

Lancaster, California, 93534, United States

Location

Argus Research

Cape Coral, Florida, 33904, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Chicago Cornea Consultants

Hoffman Estates, Illinois, 60169, United States

Location

JacksonEye

Lake Villa, Illinois, 60046, United States

Location

Discover Vision Centers

Leawood, Kansas, 66211, United States

Location

Opthalmic Consultants of Boston

Waltham, Massachusetts, 02451, United States

Location

Talamo Hatch Laser Eye Consultants

Waltham, Massachusetts, 02451, United States

Location

Associated Eye Care

Stillwater, Minnesota, 55082, United States

Location

Comprehensive Eye Care

Washington, Missouri, 63090, United States

Location

Alterman, Modi and Wolter

Poughkeepsie, New York, 12603, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

R & R Eye Research

San Antonio, Texas, 78229, United States

Location

See Clearly Vision Group

McLean, Virginia, 22102, United States

Location

MeSH Terms

Conditions

Corneal Endothelial Cell Loss; Eye Pain

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neurologic Manifestations

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 1, 2014
• Study Start: May 31, 2014
• Primary Completion: February 28, 2015
• Study Completion: April 30, 2015
• Last Updated: June 3, 2025
• Results First Posted: May 26, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (15)