A Study to Evaluate THR-317 Treatment for Macular Telangi... | NCT03669393

Studies
A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)

NCT03669393

Sponsor

ThromboGenics

Status

Completed

Last Update Posted

Sep 2, 2020Actual

Enrollment

8Actual

Phase

Phase 2

Conditions

Retinal Telangiectasis
Idiopathic Juxtafoveal Retinal Telangiectasia

Interventions

THR-317 8mg

Countries

France
Switzerland

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

ID	Type	Description	Link
2017-004010-26	EudraCT Number

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2018Actual

Primary Completion Date

Nov 22, 2019Actual

Completion Date

Nov 22, 2019Actual

First Submitted Date

Sep 10, 2018

First Submission Date that Met QC Criteria

Sep 11, 2018

First Posted Date

Sep 13, 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

Sep 1, 2020

Last Update Posted Date

Sep 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1).

Detailed Description

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
THR-317	Experimental		Drug: THR-317 8mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
THR-317 8mg	Drug	3 intravitreal injections of THR-317 8mg, approximately 1 month apart	THR-317

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)		At Day 84 (Month 3)

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in CST, based on SD-OCT, by study visit		From baseline to Day 140
Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit		From baseline to Day 140

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18 years or older
Macular oedema caused by MacTel 1, with CST >300µm on SD-OCT
Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

Type 1 or type 2 Diabetes Mellitus
Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results
Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
Any active ocular / intraocular infection or inflammation in either eye
Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Department	Oxurion NV.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Lariboisière		Paris		75010	France
Hôpital Cochin

Condition Browse Module

MeSH Terms

ID	Term
D058456	Retinal Telangiectasis
C548027	Idiopathic Juxtafoveal Retinal Telangiectasia

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D013684	Telangiectasis
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided