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Monoclonal Antibodies

THR-687 selected dose level for Diabetes (INTEGRAL Trial)

Phase 2
Waitlist Available
Research Sponsored by Oxurion
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 up to end of study (part a up to month 6 and part b up to month 8)
Awards & highlights

Summary

This trial tests two doses of a new eye drug, THR-687, against an existing drug, Aflibercept. It involves patients who are either new to treatment or have been treated before. The goal is to see which drug works better and is safer for improving eye health.

Eligible Conditions
  • Diabetic Macular Edema
  • Diabetes
  • Diabetic Retinopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of study (part a up to month 6 and part b up to month 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of study (part a up to month 6 and part b up to month 8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)

Side effects data

From 2020 Phase 4 trial • 26 Patients • NCT03022292
4%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Part B, treatment naïve subjects, THR-687 selected dose levelExperimental Treatment1 Intervention
Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected
Group II: Part B, previously treated subjects, THR-687 selected dose levelExperimental Treatment1 Intervention
Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected
Group III: Part A, THR-687 2.0mgExperimental Treatment1 Intervention
Group IV: Part A, THR-687 1.2 mgExperimental Treatment1 Intervention
Group V: Part B, treatment naïve subjects, aflibercept 2.0mgActive Control1 Intervention
Group VI: Part B, previously treated subjects, aflibercept 2.0mgActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THR-687 dose level 1
2018
Completed Phase 1
~20
THR-687 dose level 2
2018
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

OxurionLead Sponsor
4 Previous Clinical Trials
726 Total Patients Enrolled
Clinical DepartmentStudy DirectorOxurion
9 Previous Clinical Trials
358 Total Patients Enrolled
~4 spots leftby Sep 2025
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