NCT03736655

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

November 6, 2018

Last Update Submit

December 3, 2021

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (2)

  • Assess post-op IOP reduction

    Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%

    6 months

  • Assess post-op IOP clinical success

    Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg

    6 months

Study Arms (1)

Interposition supraciliary implant

EXPERIMENTAL

Any patients corresponding to inclusion / exclusion criteria

Device: Interposition supraciliary implant

Interventions

Interposition supraciliary implantDEVICE

Surgical placement of an interposition supraciliary implant in the supraciliary space

Interposition supraciliary implant

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of POAG Schafer 3 or 4
  • Medicated IOP ≥ 21

You may not qualify if:

  • Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
  • Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, …)
  • Medical treatment having intraocular hypotensive effect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Paris Saint Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Philippe SOURDILLE

    Ciliatech

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 9, 2018

Study Start

March 15, 2019

Primary Completion

April 1, 2021

Study Completion

October 25, 2021

Last Updated

December 20, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)