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

Cataract Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128113
• Other study ID #: RTA 408-C-1309
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2014
• Est. completion date: April 30, 2015

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: April 30, 2015
• Est. primary completion date: February 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Vehicle Ophthalmic Solution
Opthalmic suspension manufactured to mimic RTA 408 suspension
• Omaveloxolone Ophthalmic Suspension 0.5%
0.5% ophthalmic suspension of RTA 408
• Omaveloxolone Ophthalmic Suspension 1%
1% ophthalmic suspension of RTA 408

Locations

Country	Name	City	State
United States	Argus Research	Cape Coral	Florida
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Chicago Cornea Consultants	Hoffman Estates	Illinois
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Harvard Eye Associates	Laguna Hills	California
United States	JacksonEye	Lake Villa	Illinois
United States	Hull Eye Center	Lancaster	California
United States	Discover Vision Centers	Leawood	Kansas
United States	See Clearly Vision Group	McLean	Virginia
United States	Alterman, Modi and Wolter	Poughkeepsie	New York
United States	R & R Eye Research	San Antonio	Texas
United States	Associated Eye Care	Stillwater	Minnesota
United States	Opthalmic Consultants of Boston	Waltham	Massachusetts
United States	Talamo Hatch Laser Eye Consultants	Waltham	Massachusetts
United States	Comprehensive Eye Care	Washington	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery	Absence of of anterior chamber cells is defined as anterior chamber cells = 0	2 weeks
Secondary	Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery	Absence of of anterior chamber flare is defined as anterior chamber flare = 0	2 weeks
Secondary	Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery	Absence of of anterior chamber cells + flare is defined as anterior chamber cells + flare = 0	2 weeks
Secondary	Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery		1 day
Secondary	Change From Baseline in Central Corneal Endothelial Cell Counts	Count of central corneal endothelial cells 6 weeks post cataract surgery, compared to baseline	6 weeks