Clinical trial NCT04097730: Steroids and Cross-linking for Ulcer Treatment
Official title: Steroids and Cross-linking for Ulcer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratitis Bacterial
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Aravind Eye Care System
name: National Eye Institute (NEI)
name: University of Miami
name: Stanford University
First posted: 2019-09-20
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Mycobacteria)
* Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse
* Corneal thickness ≥350 µm, as measured on AS-OCT
* Age over 18 years
* Basic understanding of the study as determined by the physician
* Commitment to return for follow up visits

Exclusion Criteria:

* Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthameoba on gram stain)
* Impending or frank perforation at recruitment
* Involvement of sclera at presentation
* Non-infectious or autoimmune keratitis
* History of corneal transplantation or recent intraocular surgery
* Pinhole visual acuity worse than 20/200 in the unaffected eye
* Participants who are decisionally and/or cognitively impaired

Primary outcomes:
measure: Best Spectacle-Corrected Visual Acuity
timeFrame: 6 Months
Secondary outcomes:
measure: Best Spectacle-Corrected Visual Acuity
timeFrame: 3 Weeks, 3 Months, 12 Months
measure: Number of Ulcers Testing Positive for Bacteria on Repeat Culture
timeFrame: 2 Days
measure: Scar Size
timeFrame: 3 Weeks, 3 Months, 6 Months 12 Months
measure: Scar Depth
timeFrame: 3 Weeks, 3 Months, 6 Months, 12 Months
measure: Adverse Events
timeFrame: 12 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Francis I. Proctor Foundaiton
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Madurai
country: India
facility: Aravind Eye Care System
state: Tamil Nadu
Study officials:
affiliation: University of California, San Francisco
name: Tom Lietman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jennifer Rose-Nussbaumer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Nicole Varnado, MPH
role: STUDY_DIRECTOR
References:
citation: 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.