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

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

Randomized, Double-masked, Placebo-controlled Evaluation of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248037
• Other study ID #: 2017-003
• Status: Completed
• Phase: Phase 3
• Start date: September 5, 2017
• Est. completion date: July 9, 2019

Study information

• Verified date: January 2021
• Source: Cornea Research Foundation of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bullous Keratopathy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• Netarsudil
netarsudil opthalmic solution 0.02%
• Placebo
Placebo eye drops

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Cornea Research Foundation of America

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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