A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Phase 2

Completed

• Conditions: Corneal Edema
• Interventions: Drug: Netarsudil Ophthalmic

• Registration Number: NCT04498169
• Lead Sponsor: Aerie Pharmaceuticals

Brief Summary

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-04
• Study Start: 2020-09-17
• Primary Completion: 2021-08-11
• Study Completion: 2021-08-11
• Status Verified: 2022-08
• Results First Submitted: 2022-08-10
• Results First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-31
• Results First Posted: 2022-09-01
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Adults aged 18 years or older
2. Documented diagnosis of FCD
3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)

Exclusion Criteria

1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Once Daily Netarsudil Ophthalmic Solution	Netarsudil Ophthalmic	One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.
Twice Daily Netarsudil Ophthalmic Solution	Netarsudil Ophthalmic	One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.

Primary Outcome Measures

Name	Time	Method
Central Corneal Thickness (CCT)	Baseline & 4 weeks	Mean change from baseline in CCT by ultrasound pachymetry

Trial Locations

Locations (11)

Orange County Ophthalmology; 🇺🇸 Garden Grove, California, United States

Comprehensive Eye Care; 🇺🇸 Westerville, Ohio, United States

Cincinnati Eye Institute; 🇺🇸 Edgewood, Kentucky, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States

Ophthalmology Associates; 🇺🇸 Saint Louis, Missouri, United States

Chu Vision Institute; 🇺🇸 Bloomington, Minnesota, United States

Minnesota Eye Care; 🇺🇸 Minnetonka, Minnesota, United States

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States

Advance Eye Associates; 🇺🇸 South Dartmouth, Massachusetts, United States