Steroids and Cross-linking for Ulcer Treatment

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas M. Lietman
• Collaborators: Aravind Eye Care System; Kaiser Permanente; National Eye Institute (NEI); Stanford University; University of Miami
• Treatments: Difluprednate; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Riboflavin

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