Study of a Novel Interposition Supraciliary Implant in Pa... | NCT03736655

Studies
Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

NCT03736655

Sponsor

Ciliatech

Status

Terminated

Last Update Posted

Dec 20, 2021Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Glaucoma, Open-Angle

Interventions

Interposition supraciliary implant

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID

Expanded Access Info

Start Date

Mar 15, 2019Actual

Primary Completion Date

Apr 1, 2021Actual

Completion Date

Oct 25, 2021Actual

First Submitted Date

Nov 6, 2018

First Submission Date that Met QC Criteria

Nov 7, 2018

First Posted Date

Nov 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2021

Last Update Posted Date

Dec 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

68 patients will be included in this 5 years interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of an interposition supraciliary permanent device.

Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interposition supraciliary implant	Experimental	Any patients corresponding to inclusion / exclusion criteria	Device: Interposition supraciliary implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interposition supraciliary implant	Device	Surgical placement of an interposition supraciliary implant in the supraciliary space	Interposition supraciliary implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of POAG Schafer 3 or 4
Medicated IOP ≥ 21

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe SOURDILLE	Ciliatech	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Paris Saint Joseph		Paris		75014	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided