Clinical trial NCT04498169: A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Official title: A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Corneal Edema
Keywords: Corneal Edema
Fuchs Corneal Dystrophy
Netarsudil Ophthalmic Solution
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Central Corneal Thickness (CCT)
timeFrame: Baseline & 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Orange County Ophthalmology
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: South Dartmouth
country: United States
facility: Advance Eye Associates
state: Massachusetts
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Minnetonka
country: United States
facility: Minnesota Eye Care
state: Minnesota
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: W. Fargo
country: United States
facility: Vance Thompson Vision
state: North Dakota
city: Westerville
country: United States
facility: Comprehensive Eye Care
state: Ohio
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Aerie Pharmaceuticals Inc.
name: Michelle Senchyna, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy. J Ocul Pharmacol Ther. 2022 Dec;38(10):657-663. doi: 10.1089/jop.2022.0069. Epub 2022 Nov 3.