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New treatment option for Fuchs Endothelial Corneal Dystrophy
Official title Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy
ClinicalTrials.gov ID: NCT04440280
What this study is testing
What is N-acetyl cysteine (NAC) 10% solution?
N-acetyl cysteine (NAC) 10% solution is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for fuchs endothelial corneal dystrophy.
Also referred to as acetylcysteine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join 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 likely can't join 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
See the full eligibility criteria
- 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
- 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. \-
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.