Fuchs' Endothelial DystrophyPhase 2NCT04676737
TTHX1114(NM141) in Combination With DWEK/DSO
A Phase 2 study testing TTHX1114(NM141) in people with Fuchs' Endothelial Dystrophy and Fuchs Dystrophy, run by Trefoil Therapeutics, Inc. at 11 sites in United States.
Trial summary
Open label, single-treatment, with a concurrent non-treatment control Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Fuchs
- What is being tested?
- TTHX1114(NM141)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Feb 2021to 13 Jan 2023
- 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
- Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months
- Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm
- Subjects in Group 2 must have a stable Fellow Eye with adequate function
Who cannot join
- Secondary corneal/ocular pathology in the Study Eye
- Prior refractive surgery in the Study Eye
- Prior exposure to TTHX1114
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Vance Thompson Vision - Bozeman
Bozeman, Montana, 59718
Trefoil Investigational Site 120
Cincinnati, Ohio, 45242
Trefoil Investigational Site 123
Deerfield Beach, Florida, 33064
Trefoil Investigational Site 119
Fort Myers, Florida, 33907
Price Vision Group
Indianapolis, Indiana, 46260
Tauber Eye Center
Kansas City, Missouri, 64111
Trefoil Investigational Site 124
Long Beach, California, 90805
Vance Thompson Vision - Omaha
Omaha, Nebraska, 68137
North Bay Eye Associates
Petaluma, California, 94954
Vance Thompson Vision - Sioux Falls
Sioux Falls, South Dakota, 57108
Vance Thompson Vision - Fargo
West Fargo, North Dakota, 58078
About this study
Official title: Phase 2 Study To Determine the Safety and Efficacy of TTHX1114(NM141) on the Regeneration and Migration of Corneal Endothelial Cells in Patients Undergoing DWEK/DSO
Open label, single-treatment, with a concurrent non-treatment control
- Conditions
- Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Fuchs
- Being tested
- TTHX1114(NM141)
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTHX1114(NM141)Drug
TTHX1114
| Study group | Role | What they receive |
|---|---|---|
| Group 1 DWEK/DSO | No intervention | Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114 |
| Group 2 TTHX1114 in combination with DWEK/DSO | Experimental | Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO Receives: Drug: TTHX1114(NM141) |
| Group 3 TTHX1114 in combination with DWEK/DSO | Experimental | Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO Receives: Drug: TTHX1114(NM141) |
| Group 1a | Experimental | Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections) Receives: Drug: TTHX1114(NM141) |
| Group 3a | Experimental | Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections) Receives: Drug: TTHX1114(NM141) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Change from baseline
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Feb 2021
- Primary completion16 Nov 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fuchs' Endothelial DystrophyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trefoil Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Tremblay, Study director, Trefoil Therapeutics.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676737
- Sponsor's protocol ID
- TTHX-002
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moloney G, Al-Zanki S, Burgos-Blasco B, Fadaifard Martinez M, Bujak M, Dhaliwal DK. Severe Corneal Flattening After Endothelial Keratoplasty: Collagen Compaction Syndrome. Cornea. 2024 Nov 7;44(5):653-658. doi: 10.1097/ICO.0000000000003752.
PubMed 39509248
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study To Determine the Safety and Efficacy of TTHX1114(NM141) on the Regeneration and Migration of Corneal Endothelial Cells in Patients Undergoing DWEK/DSO
- ClinicalTrials.gov ID
- NCT04676737
- Acronym / sponsor ID
- TTHX-002
- Conditions
- Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Fuchs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Trefoil Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 21 Dec 2020 (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.
Open label, single-treatment, with a concurrent non-treatment control
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 DWEK/DSO | No intervention | –Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114 |
| Group 2 TTHX1114 in combination with DWEK/DSO | Experimental | Drug: TTHX1114(NM141)Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO |
| Group 3 TTHX1114 in combination with DWEK/DSO | Experimental | Drug: TTHX1114(NM141)Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO |
| Group 1a | Experimental | Drug: TTHX1114(NM141)Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections) |
| Group 3a | Experimental | Drug: TTHX1114(NM141)Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months
- Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm
- Subjects in Group 2 must have a stable Fellow Eye with adequate function
Key exclusion criteria (3 listed)
- Secondary corneal/ocular pathology in the Study Eye
- Prior refractive surgery in the Study Eye
- Prior exposure to TTHX1114
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 |
|---|---|---|
| TTHX1114(NM141)TTHX1114 | Drug | Group 1a, Group 2 TTHX1114 in combination with DWEK/DSO, Group 3 TTHX1114 in combination with DWEK/DSO, Group 3a |
Primary outcome
Best Corrected Visual Acuity
Time frame: Day 28
Change from baseline
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 7 Nov 2023.
- Derived from this study: PubMed 39509248Moloney G, Al-Zanki S, Burgos-Blasco B, Fadaifard Martinez M, Bujak M, Dhaliwal DK. Severe Corneal Flattening After Endothelial Keratoplasty: Collagen Compaction Syndrome. Cornea. 2024 Nov 7;44(5):653-658. doi: 10.1097/ICO.0000000000003752.
- Individual participant dataSharing planned: No
Related trials for Fuchs' Endothelial Dystrophy
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RecruitingObservational study
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Enrolling by invitationObservational study
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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.
Thomas Tremblay study director
Trefoil Therapeutics.com
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTHX1114(NM141) in people with Fuchs' Endothelial Dystrophy and Fuchs Dystrophy, run by Trefoil Therapeutics, Inc. at 11 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 3 inclusion and 3 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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?
Best Corrected Visual Acuity (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04676737, which also lists 1 linked publication.
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 7 Nov 2023.