Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Primary Purpose
Fuchs' Endothelial Dystrophy, Bullous Keratopathy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Netarsudil
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Fuchs' Endothelial Dystrophy
Eligibility Criteria
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.
Sites / Locations
- Price Vision Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Netarsudil
Placebo
Arm Description
Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months
Placebo eye drop, dosed topically once a day for 9 months
Outcomes
Primary Outcome Measures
Intraocular Pressure
Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading.
Secondary Outcome Measures
Full Information
NCT ID
NCT03248037
First Posted
August 9, 2017
Last Updated
January 25, 2021
Sponsor
Cornea Research Foundation of America
1. Study Identification
Unique Protocol Identification Number
NCT03248037
Brief Title
Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Official Title
Randomized, Double-masked, Placebo-controlled Evaluation of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornea Research Foundation of America
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy, Bullous Keratopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Netarsudil
Arm Type
Experimental
Arm Description
Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo eye drop, dosed topically once a day for 9 months
Intervention Type
Drug
Intervention Name(s)
Netarsudil
Intervention Description
netarsudil opthalmic solution 0.02%
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo eye drops
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading.
Time Frame
from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr, MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27666015
Citation
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.
Results Reference
background
PubMed Identifier
19643499
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.
Results Reference
background
PubMed Identifier
33045216
Citation
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.
Results Reference
derived
Learn more about this trial
Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
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