Phase 2 N=307 Randomized Double-blind Prevention

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

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

Bottom Line

View on ClinicalTrials.gov: NCT02128113 ↗

Enrolled (actual)

307

Serious AEs

2.6%

Results posted

May 2023

Primary outcome: Primary: Change From Baseline in Central Corneal Endothelial Cell Counts — -243.4; -184.8; -260.3 cells/mm^2 — p=0.4529

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Vehicle Ophthalmic Solution (Drug); Omaveloxolone Ophthalmic Suspension 0.5% (Drug); Omaveloxolone Ophthalmic Suspension 1% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Biogen
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Central Corneal Endothelial Cell Counts	-238.2; -193.9; -242.2	0.4686
SECONDARY Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery	28; 41; 43; 71; 57; 56	0.0647
SECONDARY Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery	11; 11; 14; 88; 87; 85	0.9258
SECONDARY Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery	29; 42; 44; 70; 56; 55	0.0657
SECONDARY Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery	19; 19; 18; 81; 81; 84	0.8771
SECONDARY Change From Baseline in Central Corneal Endothelial Cell Counts	-238.2; -193.9; -242.2	0.4686

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02128113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.