Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy
Who is this study for? Patients with Fuchs Endothelial Corneal Dystrophy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• Male or female ≥21 years of age at time of surgical evaluation.
• Diagnosis of advanced FECD and visually significant cataract
• Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent cataract surgery
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
• Willingness and ability to adhere to medication regimen
Locations
United States
Massachusetts
Massachusetts Eye and Ear Infirmary
RECRUITING
Boston
Contact Information
Primary
Michael Cheung, MSc, CCRP
mcheung0@meei.harvard.edu
6175736060
Backup
Ula Jurkunas, MD
Ula_Jurkunas@meei.harvard.edu
617-573-4330
Time Frame
Start Date: 2020-09-16
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 45
Treatments
Active_comparator: NAC 10% group
Subjects in this group will be treated with eye drops containing a 10% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.
Active_comparator: NAC 20% group
Subjects in this group will be treated with eye drops containing a 20% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.
Placebo_comparator: Placebo group
Subjects in this group will be treated with a placebo (Visine Tears Dry Eye Relief artificial tears ophthalmic solution.)
Related Therapeutic Areas
Sponsors
Leads: Massachusetts Eye and Ear Infirmary