Clinical trial NCT05063734: A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.
Official title: A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-687 Injections and to Evaluate the Efficacy and Safety of THR-687 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Diabetic Macular Edema
Lead sponsor: Oxurion
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study
timeFrame: At Month 3
Secondary outcomes:
measure: 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
timeFrame: at Month 3
measure: Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study
timeFrame: Up to Month 8
measure: 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
timeFrame: Up to Month 8
measure: Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to End of Study (Part A up to Month 6 and Part B up to Month 8)
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Salehi Retina Institute Inc.
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado, P.C.
state: Colorado
city: Elmhurst
country: United States
facility: Retina Associates, Ltd
state: Illinois
city: Oak Forest
country: United States
facility: University Retina and macula Associates, PC
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of Central New York, PC
state: New York
city: Tulsa
country: United States
facility: Tulsa Retina Consultants
state: Oklahoma
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Austin
country: United States
facility: Austin Research Center of Retina
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, P.A.
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group
state: Texas
city: Tallinn
country: Estonia
facility: Eye Clinic Dr Krista Turman
city: Tallinn
country: Estonia
facility: Silmalaser OU
city: Pécs
country: Hungary
facility: Ganglion Medical Center
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros klinikos
Study officials:
affiliation: Oxurion
name: Clinical Department
role: STUDY_DIRECTOR
References: