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TTHX1114(NM141) for Fuchs' Dystrophy

Phase 2
Waitlist Available
Research Sponsored by Trefoil Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights

Study Summary

This trial is open to anyone who wants to participate, there is only one treatment given and there is a control group who do not receive the treatment.

Eligible Conditions
  • Fuchs' Dystrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Corrected Visual Acuity

Side effects data

From 2021 Phase 1 & 2 trial • 22 Patients • NCT04520321
14%
Iritis
14%
Photophobia
14%
Eye irritation
14%
Punctate keratitis
14%
Eye pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
High-dose
Vehicle (Placebo)
Low Dose
Mid-dose

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Group 3aExperimental Treatment1 Intervention
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)
Group II: Group 3 TTHX1114 in combination with DWEK/DSOExperimental Treatment1 Intervention
Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO
Group III: Group 2 TTHX1114 in combination with DWEK/DSOExperimental Treatment1 Intervention
Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO
Group IV: Group 1aExperimental Treatment1 Intervention
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 V: Group 1 DWEK/DSOActive Control1 Intervention
Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TTHX1114(NM141)
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Trefoil Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
71 Total Patients Enrolled
Thomas TremblayStudy DirectorTrefoil Therapeutics.com
2 Previous Clinical Trials
49 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there different sites within the United States testing this clinical trial?

"This clinical trial is recruiting at 12 different locations, such as Trefoil Investigational Site 123 in Deerfield Beach, Vance Thompson Vision - Sioux Falls in Sioux Falls, and Trefoil Investigational Site 106 in Kansas City."

Answered by AI

When will TTHX1114(NM141) be available to the general public?

"TTHX1114(NM141) is a Phase 2 medication, meaning that while there is not yet data to support its efficacy, there have been no major safety concerns raised in clinical trials."

Answered by AI

Are there any patients currently being sought for this trial?

"This particular clinical trial, as indicated by the information available on clinicaltrials.gov, is not currently looking for patients. The study was first posted on February 1st 2021 and was most recently edited on January 21st 2022. Although this clinical trial is not recruiting candidates anymore, there are 13 other trials currently enrolling patients right now."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Trefoil Investigational Site 124
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
TTHX1114(NM141) in Combination With DWEK/DSO
2021. "TTHX1114(NM141) in Combination With DWEK/DSO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04676737.
~12 spots leftby Apr 2025
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