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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