Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

NCT04051463 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2019-007
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.

Conditions

Fuchs Endothelial Dystrophy

Outcome Measures

Primary Outcomes (1)

• Change in Central Corneal Thickness

  Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline

  1 month

Secondary Outcomes (1)

• Change in Corrected Distance Visual Acuity (CDVA)

  3 months

Study Arms (2)

Netarsudil

ACTIVE COMPARATOR

A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.

Drug: Netarsudil Ophthalmic Solution

Placebo

PLACEBO COMPARATOR

A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.

Drug: Placebo

Interventions

Netarsudil Ophthalmic Solution DRUG

Netarsudil eye drops instilled once daily

Also known as: Rhopressa

Netarsudil

Placebo DRUG

Placebo eye drops instilled once daily

Also known as: Rhopressa vehicle without active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.
• Patient is able and willing to administer eye drops.
• Patient is able to comprehend and has signed the Informed Consent form.

You may not qualify if:

• Active intraocular inflammation, corneal ulceration, keratitis, or conjunctivitis.
• Known sensitivity to any of the ingredients in the study medications.
• Abnormal eyelid function.
• History of herpetic keratitis.
• History of non-compliance with using prescribed medication.
• Current or planned pregnancy within the study duration.
• Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study.
• Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.

Sponsors & Collaborators

• Price Vision Group: lead

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Related Publications (1)

• Price MO, Price FW Jr. Randomized, Double-Masked, Pilot Study of Netarsudil 0.02% Ophthalmic Solution for Treatment of Corneal Edema in Fuchs Dystrophy. Am J Ophthalmol. 2021 Jul;227:100-105. doi: 10.1016/j.ajo.2021.03.006. Epub 2021 Mar 15.

  PMID: 33737034 RESULT

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Marianne Price
• Organization: Cornea Research Foundation of America

mprice@cornea.org

317-814-2990

Study Officials

• Francis W Price, Jr, MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The active drug and placebo will be provided in 2.5 ml bottles identical, in appearance. Only the designated dosing coordinator is unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 9, 2019
• Study Start: August 5, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 19, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)