Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
A Multi-Center, Three-Stage, Open-Label, Prospective, Active-Comparator-Controlled Phase 2a Study of ENV515 (Travoprost) Intracameral Implant in Patients With Bilateral Ocular Hypertension or Early Primary Open-Angle Glaucoma
1 other identifier
interventional
41
1 country
14
Brief Summary
This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2015
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2019
CompletedResults Posted
Study results publicly available
October 17, 2019
CompletedOctober 17, 2019
September 1, 2019
4.1 years
February 20, 2015
July 15, 2019
September 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)
Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only.
Baseline and Day 25
Study Arms (3)
Cohort 1
EXPERIMENTALENV515-1 and ENV515-3 implants in Study Eye for 28 days
Cohort 2
EXPERIMENTALTwo ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months)
Cohort 3
EXPERIMENTALOne or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of either ocular hypertension or open angle glaucoma in both eyes.
- Are currently treated with topical PGA for ocular hypertension in both eyes.
- Patients who in the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.
You may not qualify if:
- Eye surgery (including cataract surgery) within the past 3 months.
- History of glaucoma related surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Chandler, Arizona, 85225, United States
Unknown Facility
Garden Grove, California, 92843, United States
Unknown Facility
Inglewood, California, 90301, United States
Unknown Facility
Redding, California, 96002, United States
Unknown Facility
Morrow, Georgia, 30260, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Chesterfield, Missouri, 63017, United States
Unknown Facility
Kansas City, Missouri, 64133, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Sioux Falls, South Dakota, 57108, United States
Unknown Facility
Austin, Texas, 78731, United States
Unknown Facility
Houston, Texas, 77025, United States
Unknown Facility
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kristin Blackwell, Consultant, Regulatory Affairs & Quality Assurance
- Organization
- Envisia Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2015
First Posted
February 26, 2015
Study Start
January 1, 2015
Primary Completion
February 13, 2019
Study Completion
February 13, 2019
Last Updated
October 17, 2019
Results First Posted
October 17, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share