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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
Male or female aged 18 years or older at the time of signing the informed consent
Type 1 or type 2 diabetes
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
INTEGRAL Trial Summary
This study is evaluating whether a drug called THR-687 is safe and effective for treating wet AMD.
Eligible Conditions
- Diabetes
- Diabetic Retinopathy
- Diabetic Macular Edema
INTEGRAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowINTEGRAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to end of study (part a up to month 6 and part b up to month 8)
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study
Secondary outcome measures
Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study
Change From Baseline in Central Subfield Thickness (CST), Based on Spectral Domain Optical Coherence Tomography (SD-OCT), as Assessed by the Central Reading Center (CRC), by Study Visit, in Treatment-naïve Subjects in Part B of the Study
Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)
+1 moreSide effects data
From 2020 Phase 4 trial • 26 Patients • NCT030222924%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment
INTEGRAL 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, previously treated subjects, aflibercept 2.0mgActive Control1 Intervention
Group VI: Part B, treatment naïve 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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