Glaucoma and Ocular HypertensionPhase 2NCT02371746

Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma

A Phase 2 study testing ENV515-3 Travoprost XR, ENV515-1 Travoprost XR and ENV515-3-2 Travoprost XR in people with Glaucoma and Ocular Hypertension, run by Envisia Therapeutics at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Glaucoma and Ocular Hypertension
What is being tested?: ENV515-3 Travoprost XR, ENV515-1 Travoprost XR and ENV515-3-2 Travoprost XR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 14 sitesUnited States
Study dates: 1 Jan 2015to 13 Feb 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.

Who cannot join

Eye surgery (including cataract surgery) within the past 3 months.
History of glaucoma related surgery.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Study site
Austin, Texas, 78731
Study site
Chandler, Arizona, 85225
Study site
Chesterfield, Missouri, 63017
Study site
Cincinnati, Ohio, 45242
Study site
Garden Grove, California, 92843
Study site
Houston, Texas, 77025
Study site
Indianapolis, Indiana, 46260
Study site
Inglewood, California, 90301
Study site
Kansas City, Missouri, 64133
Study site
Morrow, Georgia, 30260
Study site
Portland, Oregon, 97210
Study site
Redding, California, 96002
Study site
San Antonio, Texas, 78229
Study site
Sioux Falls, South Dakota, 57108

Other trials in United States

About this study

Official title: 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

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.

Conditions: Glaucoma and Ocular Hypertension
Being tested: ENV515-3 Travoprost XR, ENV515-1 Travoprost XR, ENV515-3-2 Travoprost XR
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ENV515-3 Travoprost XRDrug
ENV515-1 Travoprost XRDrug
ENV515-3-2 Travoprost XRDrug

Study groups in NCT02371746
Study group	Role	What they receive
Cohort 1	Experimental	ENV515-1 and ENV515-3 implants in Study Eye for 28 days Receives: Drug: ENV515-3 Travoprost XR; Drug: ENV515-1 Travoprost XR
Cohort 2	Experimental	Two ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months) Receives: Drug: ENV515-3 Travoprost XR
Cohort 3	Experimental	One or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months) Receives: Drug: ENV515-3-2 Travoprost XR

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201513 Feb 2019

First posted26 Feb 2015 (estimated)
Study start1 Jan 2015
Primary completion13 Feb 2019
Study completion13 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Glaucoma and Ocular HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02371746
Sponsor's protocol ID: ENV515-01
Status last verified: Sep 2019
First submitted: 20 Feb 2015
Last updated: 17 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension

All Glaucoma and Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02371746
Acronym / sponsor ID: ENV515-01
Conditions: Glaucoma and Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Envisia TherapeuticsIndustry (pharma, biotech, devices)
Study start: 1 Jan 2015 (actual)
Primary completion: 13 Feb 2019 (actual)
Study completion: 13 Feb 2019 (actual)
First posted: 26 Feb 2015 (estimated)
Results: Posted 17 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1	Experimental	Drug: ENV515-3 Travoprost XR, Drug: ENV515-1 Travoprost XRENV515-1 and ENV515-3 implants in Study Eye for 28 days
Cohort 2	Experimental	Drug: ENV515-3 Travoprost XRTwo ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months)
Cohort 3	Experimental	Drug: ENV515-3-2 Travoprost XROne or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

Eye surgery (including cataract surgery) within the past 3 months.
History of glaucoma related surgery.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ENV515-3 Travoprost XR	Drug	Cohort 1, Cohort 2
ENV515-1 Travoprost XR	Drug	Cohort 1
ENV515-3-2 Travoprost XR	Drug	Cohort 3

Primary outcome

Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)
Time frame: Baseline and Day 25
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.

Results and safety

Results posted to the registry on 17 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 - Group 1	7	7
Cohort 1 - Group 2	10	10
Cohort 1 - Group 3	2	2
Cohort 1 - Group 4	2	2
Cohort 2	5	5
Cohort 3 - Group 1	6	6
Cohort 3 - Group 2	9	8

Primary outcome: Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)

Time frame: Baseline and Day 25. Mean (Standard Deviation). Unit: mm Hg

Measure	Cohort 1 - Group 1 n = 7	Cohort 1 - Group 2 n = 10	Cohort 1 - Group 3 n = 2	Cohort 1 - Group 4 n = 2	Cohort 2 n = 0	Cohort 3 - Group 1 n = 0	Cohort 3 - Group 2 n = 0
Value	-5.10 (1.707)	-6.65 (2.076)	-3.17 (1.179)	-5.67 (0.000)	–	–	–

Cohort 1 - Group 1 vs Cohort 1 - Group 2 vs Cohort 1 - Group 3 vs Cohort 1 - Group 4: Change from baseline: 30.4 (95% CI -1.8 to 36.6), p <0.001, ANCOVA

Population analysed: Safety Population

Adverse events

Time frame: Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - Group 1	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Cohort 1 - Group 2	1 of 10 (10%)	7 of 10 (70%)	0 of 10
Cohort 2 - Group 3	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 1 - Group 4	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 2	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Cohort 3 - Group 1	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 3 - Group 2	4 of 9 (44.4%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Glaucoma and Ocular Hypertension

Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1) (time frame: Baseline and Day 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02371746.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.