NCT04440280 Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy
| NCT ID | NCT04440280 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Fuchs Endothelial Corneal Dystrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2020-09-16 |
| Primary Completion | 2026-04-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2020-09-16 with a primary completion date of 2026-04-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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. \-
Contact & Investigator
Ula Jurkunas, MD
PRINCIPAL INVESTIGATOR
Mass Eye and Ear
Frequently Asked Questions
Who can join the NCT04440280 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Fuchs Endothelial Corneal Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04440280 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04440280 currently recruiting?
Yes, NCT04440280 is actively recruiting participants. Contact the research team at mcheung0@meei.harvard.edu for enrollment information.
Where is the NCT04440280 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04440280 clinical trial?
NCT04440280 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Ula Jurkunas, MD at Mass Eye and Ear. The trial plans to enroll 45 participants.