Netarsudil Use After Descemetorhexis Without Endothelial Keratoplasty

NCT04057053 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 18-101H2019P000908
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aim of the study is to determine whether a rho kinase inhibitor, Netarsudil, can speed corneal clearance after DWEK. Secondary aim of the study is to investigate whether patient factors, such as baseline age, pachymetry, or endothelial cell count influence response to Netarsudil.

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Keywords

DWEK, Netarsudil

Outcome Measures

Primary Outcomes (1)

• Time to corneal clearance

  Through study completion, an average of 6 months

Study Arms (2)

Netarsudil use

EXPERIMENTAL

Patient eye undergoes cataract surgery + DWEK, immediately after surgery Netarsudil 0.02% ophthalmic 1 drop daily is used in the operative eye until corneal clearance is documented.

Drug: Netarsudil 0.02% Ophthalmic Solution

Standard of care + possible rescue drop

ACTIVE COMPARATOR

Patient eye undergoes cataract surgery + DWEK, no Netarsudil is used after surgery, if cornea is not cleared in time for first eye Netarsudil 0.02% ophthalmic 1 drop dailyadded daily as possible rescue drop and time to corneal clearance is documented

Drug: Netarsudil 0.02% Ophthalmic Solution

Interventions

Netarsudil 0.02% Ophthalmic Solution DRUG

Use of Netarsudil 0.02% ophthalmic solution daily after surgery

Netarsudil use; Standard of care + possible rescue drop

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract in both eyes
• Fuchs endothelial dystrophy in both eyes

You may not qualify if:

• History of ocular surgery in one eye and not the other
• History of significant ocular trauma/burn in one eye and not the other
• Inability to provide informed consent
• Inability to undergo eye surgery
• Inablity to use eye drops reliably

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Interventions

netarsudil; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Emma E Davies

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

• Roberto Pineda

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

• Ula Jurkunas

  Massachusetss Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Model Details: This is a pilot study to determine whether there is any benefit to using Netarsudil after DWEK surgery. The study plans to enroll 10 patients (20 eyes) with Fuchs endothelial dystrophy and cataract to under combined cataract surgery with DWEK sequentially in both eyes. The first eye will be treated with Netarsudil after surgery and time to clearance will be noted. The second eye will not be treated with Netarsudil and if time to clearance is longer than the first eye, Netarsudil will be added to test if it can be used as a "rescue" drop.

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 14, 2019
• Study Start: October 2, 2018
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)