Status:
RECRUITING
Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Fuchs Endothelial Corneal Dystrophy
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Fuchs Endothelial Corneal Dystrophy (FECD) is the most common corneal endothelial disorder and has been estimated to affect approximately 4% of the US population over the age of 40. Corneal transplant...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- History of prior intraocular surgery in study eye including cataract, glaucoma and/or retina surgery
- History of other corneal diseases, such as severe dry eye, corneal scars, pseudophakic bullous keratopathy, corneal degenerations, corneal infections
- Use of ocular prescription medications except for lubricants, hyperosmotic agents, or ocular hypotensive agents
- History of ocular surface infection within the past 30 days
- Use of systemic, inhalational, or topical N-Acetylcysteine within the past 30 days
- History of intolerance to topical N-Acetylcysteine
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- \-
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04440280
Start Date
September 16 2020
End Date
April 30 2027
Last Update
September 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114