Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation

NCT03248037 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2017-003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.

Conditions

Fuchs' Endothelial Dystrophy; Bullous Keratopathy

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading.

  from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months

Study Arms (2)

Netarsudil

EXPERIMENTAL

Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months

Drug: Netarsudil

Placebo

PLACEBO COMPARATOR

Placebo eye drop, dosed topically once a day for 9 months

Drug: Placebo

Interventions

Netarsudil DRUG

netarsudil opthalmic solution 0.02%

Netarsudil

Placebo DRUG

Placebo eye drops

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 undergoing Descemet membrane endothelial keratoplasty; patient is able and willing to administer eye drops; patient is able to comprehend and has signed the Informed Consent form; patient is likely to complete the nine-month course of the study.

You may not qualify if:

• A patient exhibiting pre-operative intraocular inflammation; a patient with a known sensitivity to any of the ingredients in the study medications; a patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study; a patient with abnormal eyelid function; a patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis; a patient who has been diagnosed with uncontrolled glaucoma, prior aqueous shunt or trabeculectomy, or with preoperative intraocular pressure \> 22 mm Hg in the potential study eye; presence of any ocular disease that would interfere with the evaluation of the study treatment (however, patients with a history of cystoid macular edema, age-related macular degeneration, corneal neovascularization, and other non-interfering comorbidities may be enrolled); a patient with a history of non-compliance with using prescribed medication; a patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study; patients who are pregnant or planning to become pregnant within the duration of the study.

Sponsors & Collaborators

• Cornea Research Foundation of America: lead

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Related Publications (3)

• Fini ME, Schwartz SG, Gao X, Jeong S, Patel N, Itakura T, Price MO, Price FW Jr, Varma R, Stamer WD. Steroid-induced ocular hypertension/glaucoma: Focus on pharmacogenomics and implications for precision medicine. Prog Retin Eye Res. 2017 Jan;56:58-83. doi: 10.1016/j.preteyeres.2016.09.003. Epub 2016 Sep 22.

  PMID: 27666015 BACKGROUND

• Vajaranant TS, Price MO, Price FW, Gao W, Wilensky JT, Edward DP. Visual acuity and intraocular pressure after Descemet's stripping endothelial keratoplasty in eyes with and without preexisting glaucoma. Ophthalmology. 2009 Sep;116(9):1644-50. doi: 10.1016/j.ophtha.2009.05.034. Epub 2009 Jul 29.

  PMID: 19643499 BACKGROUND

• Price MO, Feng MT, Price FW Jr. Randomized, Double-Masked Trial of Netarsudil 0.02% Ophthalmic Solution for Prevention of Corticosteroid-Induced Ocular Hypertension. Am J Ophthalmol. 2021 Feb;222:382-387. doi: 10.1016/j.ajo.2020.09.050. Epub 2020 Oct 10.

  PMID: 33045216 DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

netarsudil

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

3178142990

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 14, 2017
• Study Start: September 5, 2017
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: February 12, 2021
• Results First Posted: February 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)