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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02128113
First received: April 28, 2014
Last updated: February 16, 2015
Last verified: February 2015
  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: June 2015
Primary Completion Date: February 2015 (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
Laguna Hills, California, United States, 92653
Hull Eye Center
Lancaster, California, United States, 93534
United States, Florida
Argus Research
Cape Coral, Florida, United States, 33904
Levenson Eye Associates
Jacksonville, Florida, United States, 32204
United States, Illinois
Chicago Cornea Consultants
Hoffman Estates, Illinois, United States, 60169
JacksonEye
Lake Villa, Illinois, United States, 60046
United States, Kansas
Discover Vision Centers
Leawood, Kansas, United States, 66211
United States, Massachusetts
Talamo Hatch Laser Eye Consultants
Waltham, Massachusetts, United States, 02451
Opthalmic Consultants of Boston
Waltham, Massachusetts, United States, 02451
United States, Minnesota
Associated Eye Care
Stillwater, Minnesota, United States, 55082
United States, Missouri
Comprehensive Eye Care
Washington, Missouri, United States, 63090
United States, New York
Alterman, Modi and Wolter
Poughkeepsie, New York, United States, 12603
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
United States, Texas
R & R Eye Research
San Antonio, Texas, United States, 78229
United States, Virginia
See Clearly Vision Group
McLean, Virginia, United States, 22102
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: February 16, 2015
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:
Cataract
Corneal Endothelial Cell Loss
Corneal Diseases
Eye Diseases
Lens Diseases
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on March 02, 2015