Clinical trial NCT02128113: RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Corneal Endothelial Cell Loss
Ocular Pain
Ocular Inflammation
Cataract Surgery
Keywords: RTA 408
Cataract surgery
Corneal Endothelial Cells
omaveloxolone
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2014-05-01
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change From Baseline in Central Corneal Endothelial Cell Counts
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery
timeFrame: 2 weeks
measure: Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery
timeFrame: 2 weeks
measure: Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery
timeFrame: 2 weeks
measure: Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery
timeFrame: 1 day
measure: Change From Baseline in Central Corneal Endothelial Cell Counts
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Lancaster
country: United States
facility: Hull Eye Center
state: California
city: Cape Coral
country: United States
facility: Argus Research
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Lake Villa
country: United States
facility: JacksonEye
state: Illinois
city: Leawood
country: United States
facility: Discover Vision Centers
state: Kansas
city: Waltham
country: United States
facility: Opthalmic Consultants of Boston
state: Massachusetts
city: Waltham
country: United States
facility: Talamo Hatch Laser Eye Consultants
state: Massachusetts
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Washington
country: United States
facility: Comprehensive Eye Care
state: Missouri
city: Poughkeepsie
country: United States
facility: Alterman, Modi and Wolter
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: San Antonio
country: United States
facility: R & R Eye Research
state: Texas
city: McLean
country: United States
facility: See Clearly Vision Group
state: Virginia
Study officials:
References: