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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05063734
Other study ID # THR-687-002
Secondary ID 2020-000362-42
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 27, 2021
Est. completion date June 29, 2022

Study information

Verified date July 2023
Source Oxurion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date June 29, 2022
Est. primary completion date June 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: - Written informed consent obtained from the subject prior to screening procedures - 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: - Macular edema due to causes other than DME in the study eye - 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

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
Estonia Eye Clinic Dr Krista Turman Tallinn
Estonia Silmalaser OU Tallinn
Hungary Ganglion Medical Center Pécs
Hungary Szegedi Tudományegyetem Szeged
Latvia Pauls Stradins Clinical University Hospital Riga
Latvia Riga East Clinical University Hospital Riga
Lithuania Vilnius University Hospital Santaros klinikos Vilnius
United States Austin Research Center of Retina Austin Texas
United States Retina Consultants of Southern Colorado, P.C. Colorado Springs Colorado
United States Retina Associates, Ltd Elmhurst Illinois
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Salehi Retina Institute Inc. Huntington Beach California
United States Retina Consultants of Texas Katy Texas
United States Eye Care Specialists Kingston Pennsylvania
United States Retina Vitreous Surgeons of Central New York, PC Liverpool New York
United States Valley Retina Institute, P.A. McAllen Texas
United States Tennessee Retina, PC Nashville Tennessee
United States University Retina and macula Associates, PC Oak Forest Illinois
United States California Eye Specialists Medical Group, Inc. Pasadena California
United States Sierra Eye Associates Reno Nevada
United States Retinal Consultants Medical Group Sacramento California
United States Medical Center Ophthalmology Associates San Antonio Texas
United States Retina Center of Texas Southlake Texas
United States Tulsa Retina Consultants Tulsa Oklahoma
United States Strategic Clinical Research Group Willow Park Texas

Sponsors (1)

Lead Sponsor Collaborator
Oxurion

Countries where clinical trial is conducted

United States,  Estonia,  Hungary,  Latvia,  Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study 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 at Month 3
Secondary Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study 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 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. Up to End of Study (Part A up to Month 6 and Part B up to Month 8)
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