A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.
- Conditions
- Diabetes MellitusDiabetic RetinopathyDiabetic Macular Edema
- Interventions
- Drug: THR-687 dose level 1Drug: THR-687 dose level 2Drug: THR-687 selected dose level
- Registration Number
- NCT05063734
- Lead Sponsor
- Oxurion
- Brief 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).
- Detailed 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 & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A, THR-687 1.2 mg THR-687 dose level 1 - Part A, THR-687 2.0mg THR-687 dose level 2 - Part B, treatment naïve subjects, THR-687 selected dose level 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 Part B, previously treated subjects, THR-687 selected dose level 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 Part B, treatment naïve subjects, aflibercept 2.0mg Aflibercept - Part B, previously treated subjects, aflibercept 2.0mg Aflibercept -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Up to Month 8 Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to End of Study (Part A up to Month 6 and Part B up to Month 8) 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.
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
Trial Locations
- Locations (25)
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Salehi Retina Institute Inc.
🇺🇸Huntington Beach, California, United States
Retina Center of Texas
🇺🇸Southlake, Texas, United States
Retina Consultants of Texas
🇺🇸Katy, Texas, United States
Eye Clinic Dr Krista Turman
🇪🇪Tallinn, Estonia
Riga East Clinical University Hospital
🇱🇻Riga, Latvia
Tulsa Retina Consultants
🇺🇸Tulsa, Oklahoma, United States
Retina Consultants of Southern Colorado, P.C.
🇺🇸Colorado Springs, Colorado, United States
Ganglion Medical Center
🇭🇺Pécs, Hungary
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Vilnius University Hospital Santaros klinikos
🇱🇹Vilnius, Lithuania
Retina Vitreous Surgeons of Central New York, PC
🇺🇸Liverpool, New York, United States
Silmalaser OU
🇪🇪Tallinn, Estonia
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Szegedi Tudományegyetem
🇭🇺Szeged, Hungary
Tennessee Retina, PC
🇺🇸Nashville, Tennessee, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retina Associates, Ltd
🇺🇸Elmhurst, Illinois, United States
California Eye Specialists Medical Group, Inc.
🇺🇸Pasadena, California, United States
University Retina and macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
Austin Research Center of Retina
🇺🇸Austin, Texas, United States
Valley Retina Institute, P.A.
🇺🇸McAllen, Texas, United States
Strategic Clinical Research Group
🇺🇸Willow Park, Texas, United States
Retinal Consultants Medical Group
🇺🇸Sacramento, California, United States