Overview

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

Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Treatments:
Acetylcysteine
N-monoacetylcystine
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

1. Male or female ≥21 years of age at time of surgical evaluation.

2. Diagnosis of advanced FECD and visually significant cataract

3. Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent
cataract surgery

4. Written informed consent obtained from subject and ability for subject to comply with
the requirements of the study.

5. Willingness and ability to adhere to medication regimen

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation
in the study.

2. History of prior intraocular surgery in study eye including cataract, glaucoma and/or
retina surgery

3. History of other corneal diseases, such as severe dry eye, corneal scars, pseudophakic
bullous keratopathy, corneal degenerations, corneal infections

4. Use of ocular prescription medications except for lubricants, hyperosmotic agents, or
ocular hypotensive agents

5. History of ocular surface infection within the past 30 days

6. Use of systemic, inhalational, or topical N-Acetylcysteine within the past 30 days

7. History of intolerance to topical N-Acetylcysteine

8. 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.

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