A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.

Diabetes Mellitus Clinical Trial

— INTEGRAL  

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)

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
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema

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)