RECRUITING

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

Conditions

Fuchs Endothelial Corneal Dystrophy Fuchs oxidative stress N-Acetylcysteine ophthalmic drops Descemet Membrane Endothelial Keratoplasty DMEK

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-09-16

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04440280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Kevin Ma, MD

CONTACT

6175737900

kevin_ma@meei.harvard.edu

Ula Jurkunas, MD

CONTACT

617-573-4330

Ula_Jurkunas@meei.harvard.edu

Principal Investigator

Ula Jurkunas, MD

PRINCIPAL_INVESTIGATOR

Mass Eye and Ear

Study Locations (Sites)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

Ula Jurkunas, MD, PRINCIPAL_INVESTIGATOR, Mass Eye and Ear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-16

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2020-09-16

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

Fuchs
Fuchs Endothelial Corneal Dystrophy
oxidative stress
N-Acetylcysteine ophthalmic drops
Descemet Membrane Endothelial Keratoplasty
DMEK

Additional Relevant MeSH Terms

Fuchs Endothelial Corneal Dystrophy