Diabetes MellitusPhase 1NCT03511898
A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)
A Phase 1 study testing THR-149 dose level 1, THR-149 dose level 2 and THR-149 dose level 3 in people with Diabetes Mellitus and Diabetic Retinopathy, run by ThromboGenics at 7 sites in United States.
Trial summary
This study is conducted to evaluate the safety of a single intravitreal injection of THR-149. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
- What is being tested?
- THR-149 dose level 1, THR-149 dose level 2 and THR-149 dose level 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 May 2018to 22 May 2019
- Phase
- Phase 1
- 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
- Type 1 or type 2 Diabetes Mellitus
- Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye
- Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
- Written informed consent obtained from the subject prior to screening procedures
Who cannot join
- Macular edema due to causes other than DME
- Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
- Previous confounding treatments / procedures, or their planned / expected use during the study period
- Presence of neovascularization at the disc (NVD) in the study eye
- Uncontrolled glaucoma in the study eye
Show all 9Show fewer
- Any active ocular / intra-ocular infection or inflammation in either eye
- Poorly controlled Diabetes Mellitus
- Uncontrolled hypertension
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Retinal Research Center, PLLC
Austin, Texas, 78705
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Retina Consultants of Houston
Houston, Texas, 77030
Mid Atlantic Retina
Huntingdon Valley, Pennsylvania, 19006
Retina Consultants of Arizona
Phoenix, Arizona, 85053
Sierra Eye Associates
Reno, Nevada, 89502
About this study
Official title: A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-149 for the Treatment of Diabetic Macular Edema (DME)
This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.
- Being tested
- THR-149 dose level 1, THR-149 dose level 2, THR-149 dose level 3
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THR-149 dose level 1Drug
single intravitreal injection of THR-149 dose level 1
THR-149 dose level 2Drug
single intravitreal injection of THR-149 dose level 2
THR-149 dose level 3Drug
single intravitreal injection of THR-149 dose level 3
| Study group | Role | What they receive |
|---|---|---|
| THR-149 dose level 1 | Experimental | Not described Receives: Drug: THR-149 dose level 1 |
| THR-149 dose level 2 | Experimental | Not described Receives: Drug: THR-149 dose level 2 |
| THR-149 dose level 3 | Experimental | Not described Receives: Drug: THR-149 dose level 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities up to the Day 14 visit
Measured: up to Day 14
Secondary outcomes (2)
Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study
Measured: From Day 0 up to Day 84
Occurrence of laboratory abnormalities up to the end of the study
Measured: At Screening, Day 1, Day 7, Day 28 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start18 May 2018
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Department, Study director, ThromboGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511898
- Sponsor's protocol ID
- THR-149-001
- Status last verified
- Jun 2019
- First submitted
- 10 Apr 2018
- Last updated
- 13 Jun 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-149 for the Treatment of Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT03511898
- Acronym / sponsor ID
- THR-149-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- 18 May 2018 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 30 Apr 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 a single intravitreal injection of THR-149.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THR-149 dose level 1 | Experimental | Drug: THR-149 dose level 1 |
| THR-149 dose level 2 | Experimental | Drug: THR-149 dose level 2 |
| THR-149 dose level 3 | Experimental | Drug: THR-149 dose level 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 years or older
- Type 1 or type 2 Diabetes Mellitus
- Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye
- Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
- Written informed consent obtained from the subject prior to screening procedures
Key exclusion criteria (9 listed)
- Macular edema due to causes other than DME
- Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
- Previous confounding treatments / procedures, or their planned / expected use during the study period
- Presence of neovascularization at the disc (NVD) in the study eye
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-149 dose level 1single intravitreal injection of THR-149 dose level 1 | Drug | THR-149 dose level 1 |
| THR-149 dose level 2single intravitreal injection of THR-149 dose level 2 | Drug | THR-149 dose level 2 |
| THR-149 dose level 3single intravitreal injection of THR-149 dose level 3 | Drug | THR-149 dose level 3 |
Primary outcome
Incidence of dose-limiting toxicities up to the Day 14 visit
Time frame: up to Day 14
2 secondary outcomes
Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study
Time frame: From Day 0 up to Day 84
Occurrence of laboratory abnormalities up to the end of the study
Time frame: At Screening, Day 1, Day 7, Day 28 and Day 84
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 13 Jun 2019.
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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
ThromboGenics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THR-149 dose level 1, THR-149 dose level 2 and THR-149 dose level 3 in people with Diabetes Mellitus and Diabetic Retinopathy, run by ThromboGenics at 7 sites in United States.
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 5 inclusion and 9 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 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of dose-limiting toxicities up to the Day 14 visit (time frame: up to Day 14). 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 13 Jun 2019.