A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.
NCT ID: NCT05063734
Last Updated: 2023-08-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2021-08-27
2022-06-29
Brief Summary
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Detailed Description
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In Part B, in the cohort of Treatment Naïve subjects are planned to be randomized (2:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.
In Part B, in the cohort of Previously Treated subjects are planned to be randomized (1:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.
All subjects in the study will receive study treatment in one selected study eye only.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A, THR-687 1.2 mg
THR-687 dose level 1
3 intravitreal injections of THR-687 dose level 1, 1 month apart
Part A, THR-687 2.0mg
THR-687 dose level 2
3 intravitreal injections of THR-687 dose level 2, 1 month apart
Part B, treatment naïve subjects, THR-687 selected dose level
Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected
THR-687 selected dose level
3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Part B, treatment naïve subjects, aflibercept 2.0mg
Aflibercept
3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Part B, previously treated subjects, THR-687 selected dose level
Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected
THR-687 selected dose level
3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Part B, previously treated subjects, aflibercept 2.0mg
Aflibercept
3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Interventions
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THR-687 dose level 1
3 intravitreal injections of THR-687 dose level 1, 1 month apart
THR-687 dose level 2
3 intravitreal injections of THR-687 dose level 2, 1 month apart
THR-687 selected dose level
3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Aflibercept
3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female aged 18 years or older at the time of signing the informed consent
* Type 1 or type 2 diabetes
* BCVA ETDRS letter score ≥ 39 in the study eye
* CI-DME with CST of ≥ 300µm in men (or equivalent in women), measured from RPE to ILM inclusively, on SD-OCT, in the study eye
* BCVA ETDRS letter score ≥ 34 in the fellow eye
Exclusion Criteria
* Concurrent disease in the study eye, other than DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
* Any condition in the study eye that could confound the ability to detect the efficacy of the investigational medicinal product
* Previous confounding medications / interventions, or their planned administration during the study
* Presence of iris neovascularisation in the study eye
* Uncontrolled glaucoma in the study eye
* Previously received THR-687 or any other experimental therapy for DME, in either eye
* Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
* Untreated Diabetes
* Glycated haemoglobin A (HbA1c) \> 12%
* Uncontrolled hypertension
18 Years
ALL
No
Sponsors
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Oxurion
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Department
Role: STUDY_DIRECTOR
Oxurion
Locations
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Salehi Retina Institute Inc.
Huntington Beach, California, United States
California Eye Specialists Medical Group, Inc.
Pasadena, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Retina Consultants of Southern Colorado, P.C.
Colorado Springs, Colorado, United States
Retina Associates, Ltd
Elmhurst, Illinois, United States
University Retina and macula Associates, PC
Oak Forest, Illinois, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Tennessee Retina, PC
Nashville, Tennessee, United States
Austin Research Center of Retina
Austin, Texas, United States
Retina Consultants of Texas
Katy, Texas, United States
Valley Retina Institute, P.A.
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Center of Texas
Southlake, Texas, United States
Strategic Clinical Research Group
Willow Park, Texas, United States
Eye Clinic Dr Krista Turman
Tallinn, , Estonia
Silmalaser OU
Tallinn, , Estonia
Ganglion Medical Center
Pécs, , Hungary
Szegedi Tudományegyetem
Szeged, , Hungary
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Riga East Clinical University Hospital
Riga, , Latvia
Vilnius University Hospital Santaros klinikos
Vilnius, , Lithuania
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-000362-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
THR-687-002
Identifier Type: -
Identifier Source: org_study_id
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