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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Reata Pharmaceuticals, Inc.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02128113
First received: April 28, 2014
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

This study assesses the efficacy and safety of two concentrations of RTA 408 ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.


Condition Intervention Phase
Corneal Endothelial Cell Loss
Ocular Pain
Ocular Inflammation
Cataract Surgery
Drug: Placebo
Drug: 0.5% RTA 408 Ophthalmic Suspension
Drug: 1% RTA 408 Ophthalmic Suspension
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Reata Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Count of corneal endothelial cells [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Count of corneal endothelial cells 12 weeks post cataract surgery, compared to baseline


Secondary Outcome Measures:
  • Measure of inflammation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Determine number of patients who have no inflammation 2 weeks post cataract surgery according to the Standardization of Uveitis Nomenclature (SUN) Working Group Inflammatory Scoring System

  • Measure of pain [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Determine number of patients who have no pain 1 day post cataract surgery according to the National Institutes of Health (NIH) Numeric Pain Rating Scale


Estimated Enrollment: 300
Study Start Date: May 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo ophthalmic solution
Placebo ophthalmic suspension, one drop, applied twice daily for a maximum of 28 days
Drug: Placebo
Opthalmic suspension manufactured to mimic RTA 408 suspension
Experimental: 0.5% RTA 408 opthalmic suspension
0.5% RTA 408 ophthalmic suspension, one drop applied twice daily for a maximum of 28 days
Drug: 0.5% RTA 408 Ophthalmic Suspension
0.5% ophthalmic suspension of RTA 408
Experimental: 1% RTA 408 opthalmic suspension
1% RTA 408 ophthalmic suspension, one drop applied twice daily for a maximum of 28 days
Drug: 1% RTA 408 Ophthalmic Suspension
1% ophthalmic suspension of RTA 408

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 RTA 408 Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128113

Locations
United States, California
Harvard Eye Associates Recruiting
Laguna Hills, California, United States, 92653
Contact: Research Coordinator    949-900-5248      
Principal Investigator: John Hovanesian, MD         
United States, Florida
Argus Research Recruiting
Cape Coral, Florida, United States, 33904
Contact: Research Coordinator    239-542-2020      
Principal Investigator: Farrell Tyson, MD         
Levenson Eye Associates Recruiting
Jacksonville, Florida, United States, 32204
Contact: Research Coordinator    904-366-3781      
Principal Investigator: Jeffrey Levenson, MD         
United States, Illinois
Chicago Cornea Consultants Recruiting
Hoffman Estates, Illinois, United States, 60169
Contact: Research Coordinator    847-748-3553      
Principal Investigator: Parag Majmudar, MD         
JacksonEye Recruiting
Lake Villa, Illinois, United States, 60046
Contact: Research Coordinator    847-356-0700      
Principal Investigator: Mitchell Jackson, MD         
United States, Kansas
Discover Vision Centers Recruiting
Leawood, Kansas, United States, 66211
Contact: Research Coordinator    816-350-4539      
Principal Investigator: John Doane, MD         
United States, Massachusetts
Opthalmic Consultants of Boston Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Research Coordinator    617-504-9334      
Principal Investigator: Bonnie Henderson, MD         
Talamo Hatch Laser Eye Consultants Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Research Coordinator    781-890-4979 ext 25      
Principal Investigator: Jonathan Talamo, MD         
United States, Minnesota
Chu Vision Center Recruiting
Bloomington, Minnesota, United States, 55420
Contact: Research Coordinator    952-835-1235      
Principal Investigator: Ralph Chu, MD         
Associated Eye Care Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Research Coordinator    651-275-3000      
Principal Investigator: Stephen Lane, MD         
United States, Missouri
Comprehensive Eye Care Recruiting
Washington, Missouri, United States, 63090
Contact: Research Coordinator    636-390-3999      
Principal Investigator: Michael Korenfeld, MD         
United States, New York
Alterman, Modi and Wolter Recruiting
Poughkeepsie, New York, United States, 12603
Contact: Research Coordinator    845-454-1025      
Principal Investigator: Satish Modi, MD         
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Research Coordinator    513-569-3462      
Principal Investigator: Michael Snyder, MD         
United States, Texas
R & R Eye Research Recruiting
San Antonio, Texas, United States, 78229
Contact: Research Coordinator    210-340-1212      
Principal Investigator: Charles Reilly, MD         
United States, Virginia
See Clearly Vision Group Recruiting
McLean, Virginia, United States, 22102
Contact: Research Coordinator    703-827-5454      
Principal Investigator: Khoa Dang Hoang, MD         
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
AbbVie
  More Information

No publications provided

Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02128113     History of Changes
Other Study ID Numbers: RTA 408-C-1309
Study First Received: April 28, 2014
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Reata Pharmaceuticals, Inc.:
RTA 408
Cataract surgery
Corneal Endothelial Cells

Additional relevant MeSH terms:
Inflammation
Cataract
Corneal Endothelial Cell Loss
Pathologic Processes
Lens Diseases
Eye Diseases
Corneal Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on October 19, 2014