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

July 25, 2023 updated by: Oxurion

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia, 11314
        • Eye Clinic Dr Krista Turman
      • Tallinn, Estonia, 11412
        • Silmalaser OÜ
  • Hungary
      • Pécs, Hungary, 7621
        • Ganglion Medical Center
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem
  • Latvia
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, LV-1006
        • Riga East Clinical University Hospital
  • Lithuania
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santaros Klinikos
  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Salehi Retina Institute Inc.
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group, Inc.
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado, P.C.
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Retina Associates, LTD
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates, PC
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New York
      • Liverpool, New York, United States, 13088
        • Retina Vitreous Surgeons of Central New York, PC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Tulsa Retina Consultants
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
        • Eye Care Specialists
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina, PC
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Research Center of Retina
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, P.A.
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • Southlake, Texas, United States, 76092
        • Retina Center Of Texas
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A, THR-687 1.2 mg
Drug: THR-687 dose level 1
3 intravitreal injections of THR-687 dose level 1, 1 month apart
Experimental: Part A, THR-687 2.0mg
Drug: THR-687 dose level 2
3 intravitreal injections of THR-687 dose level 2, 1 month apart
Experimental: Part B, treatment naïve subjects, 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
Drug: 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.
Active Comparator: Part B, treatment naïve subjects, aflibercept 2.0mg
Drug: 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.
Other Names:
  • Eylea®
Experimental: Part B, previously treated subjects, 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
Drug: 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.
Active Comparator: Part B, previously treated subjects, aflibercept 2.0mg
Drug: 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.
Other Names:
  • Eylea®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study
Time Frame: At Month 3
At Month 3

Secondary Outcome Measures

Outcome Measure
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
Time Frame: at Month 3
at Month 3
Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study
Time Frame: Up to Month 8
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
Time Frame: Up to Month 8
Up to Month 8
Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 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.
Up to End of Study (Part A up to Month 6 and Part B up to Month 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxurion

Investigators

  • Study Director: Clinical Department, Oxurion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Actual)

June 29, 2022

Study Completion (Actual)

June 29, 2022

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THR-687-002
  • 2020-000362-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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