Back to resultsA Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)
Primary Purpose
Retinal Telangiectasis, Idiopathic Juxtafoveal Retinal Telangiectasia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
THR-317 8mg
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Telangiectasis
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
Sites / Locations
- Hôpital Lariboisière
- Hôpital Cochin
- Hôpital Ophtalmique Jules-Gonin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
THR-317
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)
Secondary Outcome Measures
Change from baseline in CST, based on SD-OCT, by study visit
Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit
Change from baseline in best-corrected visual acuity (BCVA), by study visit
Incidence of systemic and ocular adverse events including serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03669393
Brief Title
A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)
Official Title
A Phase 2, Open-label, Multi-centre Study to Assess the Efficacy and Safety of Intravitreal THR-317 for the Treatment of Macular Telangiectasia Type 1 (MacTel 1)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Telangiectasis, Idiopathic Juxtafoveal Retinal Telangiectasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THR-317
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
THR-317 8mg
Intervention Description
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
Primary Outcome Measure Information:
Title
Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)
Time Frame
At Day 84 (Month 3)
Secondary Outcome Measure Information:
Title
Change from baseline in CST, based on SD-OCT, by study visit
Time Frame
From baseline to Day 140
Title
Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit
Time Frame
From baseline to Day 140
Title
Change from baseline in best-corrected visual acuity (BCVA), by study visit
Time Frame
From Day 0 to Day 140
Title
Incidence of systemic and ocular adverse events including serious adverse events
Time Frame
From Day 0 to Day 140
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Department
Organizational Affiliation
Oxurion NV.
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hôpital Ophtalmique Jules-Gonin
City
Lausanne
ZIP/Postal Code
1000
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)
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