Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Fuchs Endothelial Corneal Dystrophy

In brief

This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.

Key facts

Study ID

NCT04440280

Run by

Massachusetts Eye and Ear Infirmary

People needed

45

Starts

2020-09-16

Expected to finish

2027-04-30

Last updated by the study team

2025-09-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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