NCT04097730|CompletedPhase 3DMCFDA Drug
Steroids and Cross-linking for Ulcer Treatment
SCUT II
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Sponsor study identifier
Secondary identifiers
NIH
interventional
280
2 countries
3
Study Start
September 24, 2020
Actual (reported)Primary Completion
May 18, 2024
Actual (reported)Study Completion
September 18, 2024
Actual (reported)Steroids and Cross-linking for Ulcer Treatment (SCUT II) is an international, randomized, double-masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus collagen cross-linking (CXL), as well as to further evaluate findings from subgroup analyses of SCUT. Patients presenting to the Aravind Eye Care System (India), Kaiser Permanente Northern California (USA), or the University of California, San Francisco (USA) with smear-positive and/or culture-positive typical (i.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of three treatment groups: Group 1: Standard therapy, topical 0.5% moxifloxacin plus topical placebo plus sham CXL Group 2: Early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham CXL Group 3: CXL plus early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus CXL
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 18, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 12, 2019
Actual (reported)September 20, 2019
Actual (reported)September 24, 2020
Actual (reported)May 18, 2024
Actual (reported)September 18, 2024
Actual (reported)Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity
6 Months
Best Spectacle-Corrected Visual Acuity
3 Weeks, 3 Months, 12 Months
Number of Ulcers Testing Positive for Bacteria on Repeat Culture
2 Days
Scar Size
3 Weeks, 3 Months, 6 Months 12 Months
Scar Depth
3 Weeks, 3 Months, 6 Months, 12 Months
Adverse Events
12 Months
Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking.
Participants in this arm will receive topical 0.5% moxifloxacin plus topical steroids plus sham corneal cross-linking.
Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is standard therapy for bacterial keratitis. Immediately after CXL/sham CXL and repeat culture, all participants will receive topical moxifloxacin drops every 1 hour for 2 days, and then every 2 hours while awake until resolution of the epithelial defect.
Francis I. Proctor Foundaiton
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33136, United States
Aravind Eye Care System
Madurai, Tamil Nadu, India
Prajna NV, Lalitha P, Chandru S, Radhakrishnan N, Christy J, Karthikeyan A, Rajaraman R, Ramesh R, Amescua G, Mandlik K, Abdelrahman S, Varnado N, Kanchugantla M, Arnold B, Lietman TM, Rose-Nussbaumer JR. Steroids and Cross-Linking for Ulcer Treatment: The SCUT II Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jul 24;143(9):723-30. doi: 10.1001/jamaophthalmol.2025.2188. Online ahead of print.
Keenan JD. Steroids in the Management of Infectious Keratitis. Cornea. 2023 Nov 1;42(11):1333-1339. doi: 10.1097/ICO.0000000000003340. Epub 2023 Jul 4.
Tom Lietman, MD
University of California, San Francisco
Jennifer Rose-Nussbaumer, MD
Stanford University
Nicole Varnado, MPH
Stanford University
280 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2019
First Posted
September 20, 2019
Study Start
September 24, 2020
Actual (reported)Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking.
Difluprednate 0.05% is a corticosteroid used to reduce inflammation in the eye. Participants will receive one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of steroid therapy.
All participants will receive a 30 minute loading dose of topical 0.1% riboflavin and 20% dextran T500 drops every 2 minutes. For participants randomized to corneal cross-linking(CXL), this will be followed by exposure to UV-A light at a wavelength of 365 nm with an irradiance of 3 mW/cm2 for 30 minutes for a total dose of 5.4 J/cm2 (UV lamp: PESCHKE Meditrade GmbH, Hueneberg, Switzerland for India; Avedro KXL System, Waltham, MA, USA for USA). During irradiation patients will continue to receive topical riboflavin at 5-minute intervals. For those randomized to sham CXL, this experience is simulated however the light will be shined adjacent to the patient, careful to avoid exposure to the cornea.
Participants randomized to topical placebo will receive topical placebo on the same medication schedule as difluprednate: one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of placebo therapy. Placebo will be the vehicle used in difluprednate.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Radhakrishnan N, Prajna VN, Prajna LS, Venugopal A, Narayana S, Rajaraman R, Amescua G, Porco TC, Lietman TM, Rose-Nussbaumer J. Double-masked, sham and placebo-controlled trial of corneal cross-linking and topical difluprednate in the treatment of bacterial keratitis: Steroids and Cross-linking for Ulcer Treatment Trial (SCUT II) study protocol. BMJ Open Ophthalmol. 2021 Nov 29;6(1):e000811. doi: 10.1136/bmjophth-2021-000811. eCollection 2021.
Primary Completion
May 18, 2024
Actual (reported)Study Completion
September 18, 2024
Actual (reported)Last Updated
February 3, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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