# Steroids and Cross-linking for Ulcer Treatment (SCUT II)

> **NIH NIH UG1** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $903,252

## Abstract

PROJECT SUMMARY/ABSTRACT
Investigating factors that mitigate the inflammatory response to infection may have the greatest impact on
clinical outcomes in bacterial keratitis. Well-designed randomized controlled trials comparing different topical
antibiotics have been unable to identify any significant difference of treatment success. Activated immune cells
secret cytokines and collagenases which lead to destruction of corneal tissue. Simultaneous treatment of
inflammation may reduce corneal astigmatism and opacity, thus improving visual acuity outcomes. The
Steroids for Corneal Ulcer Trial (SCUT) was unable to identify a benefit or harm to the use of adjuvant steroids
in the treatment of bacterial ulcers overall, however, hypothesis-generating subgroup analysis consistently
suggested a benefit in severe, non-Nocardia ulcers treated with early steroids.
Here, we propose the Steroids and Cross-linking for Ulcer Treatment II (SCUT II), an international,
randomized, double-masked, clinical trial designed to evaluate the benefit of adjuvant corneal cross-linking
(CXL) and early steroids in the treatment of bacterial ulcers. Patients presenting to one of the Aravind Eye
Hospitals in India or to UCSF with smear-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 Group, topical 0.5% moxifloxacin plus topical placebo plus sham CXL
Group 2: Early Steroid Group, topical 0.5% moxifloxacin plus topical 0.05% difluprednate plus sham CXL
Group 3: CXL Group, topical 0.5% moxifloxacin plus topical 0.05% difluprednate plus CXL
This approach is innovative for a number of reasons including its testing of novel treatments such as topical
difluprednate 0.05% and corneal cross-linking. It is also aligned with the priorities of the NEI including the study
of infectious processes, as well as studying new high-resolution imaging techniques such as confocal
microscopy, anterior-segment optical coherence and Pentacam Scheimflug imaging to guide treatment of
corneal ulceration and as potential surrogate trial endpoints in future trials. Proctor has a proven track record of
studying the optimal treatment of corneal ulceration with large NEI-funded trials. Corneal opacity remains one
of the leading causing of blindness worldwide and we anticipate that this research will guide clinicians on the
best management of cornea infection to reduce the morbidity associated with this condition.

## Key facts

- **NIH application ID:** 9986754
- **Project number:** 5UG1EY028518-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** THOMAS M LIETMAN
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $903,252
- **Award type:** 5
- **Project period:** 2019-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986754

## Citation

> US National Institutes of Health, RePORTER application 9986754, Steroids and Cross-linking for Ulcer Treatment (SCUT II) (5UG1EY028518-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9986754. Licensed CC0.

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