RECRUITING

Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2

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Conditions

Neurotrophic KeratopathyNeurotrophic KeratitisNK

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

Official Title

A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy (SEER-2)

Quick Facts

Study Start:2023-04-11
Study Completion:2024-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05555589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Shinwook Kang
CONTACT
609-734-4328
swkang@regentreellc.com
Ted Um
CONTACT
ted@regentreellc.com

Study Locations (Sites)

Harvard Eye Associates
Laguna Hills, California, 92653
United States
Loma Linda University Eye Institute
Loma Linda, California, 92354
United States
Nvision Clinical Research, LLC.
Los Angeles, California, 90013
United States
Dr. Shultz and Dr. Chan
Northridge, California, 91325
United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909
United States
Advance Vision Research Institute
Longmont, Colorado, 80503
United States
Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons
Danbury, Connecticut, 06810
United States
University of Miami
Coral Gables, Florida, 33146
United States
University of South Florida, Ophthalmolgoy
Tampa, Florida, 33612
United States
Thomas Eye Group, P.C.
Sandy Springs, Georgia, 30328
United States
Northwestern
Chicago, Illinois, 60611
United States
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
United States
Midwest Cornea Associates, LLC.
Carmel, Indiana, 46290
United States
Huffman & Huffman, PSC
Lexington, Kentucky, 40509
United States
Tufts Medical Center, Department of Ophthalmology
Boston, Massachusetts, 02111
United States
Washington University Eye Center
Saint Louis, Missouri, 63108
United States
Atlantic Eye
Eatontown, New Jersey, 07724
United States
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, 07650
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Duke Eye Center
Durham, North Carolina, 27710
United States
Oculus Research
Raleigh, North Carolina, 27617
United States
CORE, Inc. / Vita Eye Clinic
Shelby, North Carolina, 28150
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic, Cole Eye Institute
Cleveland, Ohio, 44195
United States
Pacific ClearVision Institute
Eugene, Oregon, 97401
United States
OHSU Casey Eye Institute
Portland, Oregon, 97239
United States
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
United States
Cornea Associates of Texas
Dallas, Texas, 75231
United States
Houston Eye Associates
Houston, Texas, 77025
United States
MCOA Eye Care
San Antonio, Texas, 78240
United States
University of Washington, Department of Ophthalmology
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: ReGenTree, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-11
Study Completion Date2024-11-30

Study Record Updates

Study Start Date2023-04-11
Study Completion Date2024-11-30

Terms related to this study

Keywords Provided by Researchers

  • Neurotrophic Keratitis
  • NK

Additional Relevant MeSH Terms

  • Neurotrophic Keratopathy