Retinal TelangiectasisPhase 2NCT03669393
A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)
A Phase 2 study testing THR-317 8mg in people with Retinal Telangiectasis and Idiopathic Juxtafoveal Retinal Telangiectasia, run by ThromboGenics at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Telangiectasis, Idiopathic Juxtafoveal Retinal Telangiectasia
- What is being tested?
- THR-317 8mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Sep 2018to 22 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
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)
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).
- Being tested
- THR-317 8mg
- Medical subject headings
- Retinal Telangiectasis, Idiopathic Juxtafoveal Retinal Telangiectasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THR-317 8mgDrug
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
| Study group | Role | What they receive |
|---|---|---|
| THR-317 | Experimental | Not described Receives: Drug: THR-317 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)
Measured: At Day 84 (Month 3)
Secondary outcomes (4)
Change from baseline in CST, based on SD-OCT, by study visit
Measured: From baseline to Day 140
Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit
Measured: From baseline to Day 140
Change from baseline in best-corrected visual acuity (BCVA), by study visit
Measured: From Day 0 to Day 140
Incidence of systemic and ocular adverse events including serious adverse events
Measured: From Day 0 to Day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start18 Sep 2018
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal TelangiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Department, Study director, Oxurion NV.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669393
- Sponsor's protocol ID
- THR-317-003
- Other IDs
- 2017-004010-26, 2017
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03669393
- Acronym / sponsor ID
- THR-317-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THR-317 | Experimental | Drug: THR-317 8mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THR-317 8mg3 intravitreal injections of THR-317 8mg, approximately 1 month apart | Drug | THR-317 |
Primary outcome
Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)
Time frame: At Day 84 (Month 3)
4 secondary outcomes
Change from baseline in CST, based on SD-OCT, by study visit
Time frame: From baseline to Day 140
Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit
Time frame: From baseline to Day 140
Change from baseline in best-corrected visual acuity (BCVA), by study visit
Time frame: From Day 0 to Day 140
Incidence of systemic and ocular adverse events including serious adverse events
Time frame: From Day 0 to Day 140
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Department study director
Oxurion NV.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THR-317 8mg in people with Retinal Telangiectasis and Idiopathic Juxtafoveal Retinal Telangiectasia, run by ThromboGenics at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT) (time frame: At Day 84 (Month 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.