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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02371746
Enrollment
41
Registered
2015-02-26
Start date
2015-01-01
Completion date
2019-02-13
Last updated
2019-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma and Ocular Hypertension

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.

Interventions

DRUGENV515-3 Travoprost XR
DRUGENV515-1 Travoprost XR
DRUGENV515-3-2 Travoprost XR

Sponsors

Envisia Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.

Exclusion criteria

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

Design outcomes

Primary

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

Countries

United States

Participant flow

Participants by arm

ArmCount
Cohort 1 - Group 1
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
7
Cohort 1 - Group 2
3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
10
Cohort 1 - Group 3
1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
2
Cohort 1 - Group 4
2 ENV515-3 implants (85.0 μg travoprost) in Study Eye for 28 days
2
Cohort 2
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
5
Cohort 3 - Group 1
1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
6
Cohort 3 - Group 2
2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
9
Total41

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Overall StudyConsent withdrawn0000001

Baseline characteristics

CharacteristicCohort 1 - Group 1Cohort 1 - Group 2Cohort 1 - Group 3Cohort 1 - Group 4Cohort 2Cohort 3 - Group 1Cohort 3 - Group 2Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants9 Participants2 Participants1 Participants2 Participants1 Participants6 Participants28 Participants
Age, Categorical
Between 18 and 65 years
0 Participants1 Participants0 Participants1 Participants3 Participants5 Participants3 Participants13 Participants
Age, Continuous
Cohort 1
74.32 Years
STANDARD_DEVIATION 4.729
71.99 Years
STANDARD_DEVIATION 4.213
71.29 Years
STANDARD_DEVIATION 7.128
62.46 Years
STANDARD_DEVIATION 8.188
———71.79 Years
STANDARD_DEVIATION 5.619
Age, Continuous
Cohorts 2 and 3
————57.412 Years
STANDARD_DEVIATION 11.4833
59.472 Years
STANDARD_DEVIATION 7.2299
64.462 Years
STANDARD_DEVIATION 10.4534
61.203 Years
STANDARD_DEVIATION 9.8634
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants10 Participants2 Participants1 Participants4 Participants6 Participants9 Participants37 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Intraocular Pressure (mm Hg)
Cohort 1
24.57 mm Hg
STANDARD_DEVIATION 2.37
24.12 mm Hg
STANDARD_DEVIATION 2.277
24.83 mm Hg
STANDARD_DEVIATION 3.064
26.67 mm Hg
STANDARD_DEVIATION 1.414
———24.58 mm Hg
STANDARD_DEVIATION 2.267
Intraocular Pressure (mm Hg)
Cohorts 2 and 3
————26.2 mm Hg
STANDARD_DEVIATION 2.39
28.2 mm Hg
STANDARD_DEVIATION 2.99
25.2 mm Hg
STANDARD_DEVIATION 1.56
26.4 mm Hg
STANDARD_DEVIATION 2.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants0 Participants0 Participants0 Participants1 Participants2 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants7 Participants2 Participants2 Participants5 Participants5 Participants7 Participants35 Participants
Region of Enrollment
United States
7 Participants10 Participants2 Participants2 Participants5 Participants6 Participants9 Participants41 Participants
Sex: Female, Male
Female
5 Participants3 Participants2 Participants2 Participants4 Participants2 Participants6 Participants24 Participants
Sex: Female, Male
Male
2 Participants7 Participants0 Participants0 Participants1 Participants4 Participants3 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 100 / 20 / 20 / 50 / 60 / 9
other
Total, other adverse events
4 / 77 / 102 / 22 / 25 / 56 / 69 / 9
serious
Total, serious adverse events
0 / 71 / 100 / 20 / 20 / 50 / 64 / 9

Outcome results

Primary

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.

Time frame: Baseline and Day 25

Population: Safety Population

ArmMeasureValue (MEAN)Dispersion
Cohort 1 - Group 1Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)-5.10 mm HgStandard Deviation 1.707
Cohort 1 - Group 2Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)-6.65 mm HgStandard Deviation 2.076
Cohort 1 - Group 3Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)-3.17 mm HgStandard Deviation 1.179
Cohort 1 - Group 4Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)-5.67 mm HgStandard Deviation 0
Comparison: estimatCohort 1 all Groups: Non-study eye: TRAVANTAN Z Cohort 1 - Group 1: Study Eye: 28.2 ug travoprost Cohort 1 - Group 2: Study Eye: 42.3 ug travoprost Cohort 1 - Group 3: Study Eye: 42 .5 ug travoprost Cohort 1 - Group 4: Study Eye: 85.0 ug travoprostp-value: <0.00195% CI: [-1.8, 36.6]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026