Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271772
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-14
Brief Title:
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REAGIR II
Brief Summary:
Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II REAGIR II is a randomized double-masked feasibility study The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal RB-PDT
Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive andor culture positive typical Ie non-Nocardia or Mycobacteria bacterial corneal ulcers and moderate to severe vision loss defined as Snellen visual acuity of 2040 of worse will be eligible for inclusion Those who agree to participate will be randomized to one of two treatment groups
Group 6 RB-PDT Plus Early Steroids topical 05 moxifloxacin plus topical difluprednate 005 plus RB-PDT
Group 7 Sham RB-PDT Plus Early Steroids topical 05 moxifloxacin plus topical difluprednate 005 plus sham RB-PDT
Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive andor culture positive typical Ie non-Nocardia or Mycobacteria bacterial corneal ulcers and moderate to severe vision loss defined as Snellen visual acuity of 2040 of worse will be eligible for inclusion Those who agree to participate will be randomized to one of two treatment groups
Group 6 RB-PDT Plus Early Steroids topical 05 moxifloxacin plus topical difluprednate 005 plus RB-PDT
Group 7 Sham RB-PDT Plus Early Steroids topical 05 moxifloxacin plus topical difluprednate 005 plus sham RB-PDT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None