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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000362-42 | EudraCT Number |
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Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B.
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This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).
In Part A, approximately 12 subjects are planned to be randomized (1:1 allocation) to THR-687 1.2mg and THR-687 2.0mg.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, THR-687 1.2 mg | Experimental |
| |
| Part A, THR-687 2.0mg | Experimental |
| |
| Part B, treatment naïve subjects, THR-687 selected dose level | Experimental | Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected |
|
| Part B, treatment naïve subjects, aflibercept 2.0mg | Active Comparator |
| |
| Part B, previously treated subjects, THR-687 selected dose level | Experimental | Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected |
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| Part B, previously treated subjects, aflibercept 2.0mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THR-687 dose level 1 | Drug | 3 intravitreal injections of THR-687 dose level 1, 1 month apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study | At Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Average of the Change From Baseline in BCVA ETDRS Letter Score From Day 8 Through Month 3 Using the Trapezoidal Rule (AUC), in Treatment-naïve Subjects in Part B of the Study | at Month 3 | |
| Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study |
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The subjects in this study will be subjects with central-involved DME (CI-DME). Both treatment-naïve and previously treated subjects will be included.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Department | Oxurion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salehi Retina Institute Inc. | Huntington Beach | California | 92647 | United States | ||
| California Eye Specialists Medical Group, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, THR-687 1.2mg | THR-687: 3 intravitreal injections of THR-687, 1 month apart |
| FG001 | Part A, THR-687 2.0mg | THR-687: 3 intravitreal injections of THR-687, 1 month apart |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2021 |
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| THR-687 dose level 2 | Drug | 3 intravitreal injections of THR-687 dose level 2, 1 month apart |
|
| THR-687 selected dose level | Drug | 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 | Drug | 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. |
|
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| Up to Month 8 |
| 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 | Up to Month 8 |
| Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events will be reported from the date of Informed Consent until End of the Study visit (up to Month 6 in Part A and up to Month 8 in Part B) or at the early study discontinuation visit and will be coded using MedDRA. Adverse Events will be summarized by System Organ Class and Primary Term. Incidence by subject represents at least one occurrence of the Primary Term with an onset on or after the date of the first study treatment. If a subject has multiple occurrences of an adverse event (P-term), the subject is presented only once in the respective subject count. | Up to End of Study (Part A up to Month 6 and Part B up to Month 8) |
| Pasadena |
| California |
| 91107 |
| United States |
| Retinal Consultants Medical Group | Sacramento | California | 95825 | United States |
| Retina Consultants of Southern Colorado, P.C. | Colorado Springs | Colorado | 80909 | United States |
| Retina Associates, Ltd | Elmhurst | Illinois | 60126 | United States |
| University Retina and macula Associates, PC | Oak Forest | Illinois | 60452 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Retina Vitreous Surgeons of Central New York, PC | Liverpool | New York | 13088 | United States |
| Tulsa Retina Consultants | Tulsa | Oklahoma | 74114 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Tennessee Retina, PC | Nashville | Tennessee | 37203 | United States |
| Austin Research Center of Retina | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas | Katy | Texas | 77494 | United States |
| Valley Retina Institute, P.A. | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Retina Center of Texas | Southlake | Texas | 76092 | United States |
| Strategic Clinical Research Group | Willow Park | Texas | 76087 | United States |
| Eye Clinic Dr Krista Turman | Tallinn | 11314 | Estonia |
| Silmalaser OU | Tallinn | 11412 | Estonia |
| Ganglion Medical Center | Pécs | 7621 | Hungary |
| Szegedi Tudományegyetem | Szeged | 6720 | Hungary |
| Pauls Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| Riga East Clinical University Hospital | Riga | LV-1006 | Latvia |
| Vilnius University Hospital Santaros klinikos | Vilnius | LT-08661 | Lithuania |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A, THR-687 1.2mg | THR-687: 3 intravitreal injections of THR-687, 1 month apart |
| BG001 | Part A, THR-687 2.0mg | THR-687: 3 intravitreal injections of THR-687, 1 month apart |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study | Part B of the study was not initiated due to insufficient evidence of efficacy based on the data obtained in Part A | Posted | At Month 3 |
|
| |||||||||||||||||||||||
| Secondary | Weighted Average of the Change From Baseline in BCVA ETDRS Letter Score From Day 8 Through Month 3 Using the Trapezoidal Rule (AUC), in Treatment-naïve Subjects in Part B of the Study | Part B of the study was not initiated due to insufficient evidence of efficacy based on the data obtained in Part A | Posted | at Month 3 |
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| |||||||||||||||||||||||
| Secondary | Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study | Part B of the study was not initiated due to insufficient evidence of efficacy based on the data obtained in Part A | Posted | Up to Month 8 |
|
| |||||||||||||||||||||||
| Secondary | 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 | Part B of the study was not initiated due to insufficient evidence of efficacy based on the data obtained in Part A | Posted | Up to Month 8 |
|
| |||||||||||||||||||||||
| Secondary | Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events will be reported from the date of Informed Consent until End of the Study visit (up to Month 6 in Part A and up to Month 8 in Part B) or at the early study discontinuation visit and will be coded using MedDRA. Adverse Events will be summarized by System Organ Class and Primary Term. Incidence by subject represents at least one occurrence of the Primary Term with an onset on or after the date of the first study treatment. If a subject has multiple occurrences of an adverse event (P-term), the subject is presented only once in the respective subject count. | Posted | Count of Participants | Participants | Up to End of Study (Part A up to Month 6 and Part B up to Month 8) |
|
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Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A, THR-687 1.2mg | THR-687: 3 intravitreal injections of THR-687, 1 month apart | 0 | 7 | 0 | 7 | 4 | 7 |
| EG001 | Part A, THR-687 2.0mg | THR-687: 3 intravitreal injections of THR-687, 1 month apart | 0 | 9 | 0 | 9 | 6 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract Subcapsular | Eye disorders | Systematic Assessment |
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| Diabetic Retinal Oedema | Eye disorders | Systematic Assessment |
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| Optic Disc Haemorrhage | Eye disorders | Systematic Assessment |
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| Posterior Capsule Opacification | Eye disorders | Systematic Assessment |
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| Retinal Thickening | Eye disorders | Systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Gastroenteritis Viral | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Intraocular Pressure Increased | Investigations | Systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
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| Genital Disorder | Reproductive system and breast disorders | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Department | Oxurion | +32 16 75 13 10 | info@oxurion.com |
| Jan 30, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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