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

Sponsor
Oxurion (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05063734
Collaborator
(none)
303
Enrollment
16
Locations
6
Arms
23.1
Anticipated Duration (Months)
18.9
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: THR-687 dose level 1
  • Drug: THR-687 dose level 2
  • Drug: THR-687 selected dose level
  • Drug: Aflibercept
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
303 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Aug 27, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Part A, THR-687 dose level 1

Drug: THR-687 dose level 1
3 intravitreal injections of THR-687 dose level 1, 1 month apart

Experimental: Part A, THR-687 dose level 2

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

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

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

    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

    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®
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. 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]

    3. 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]

    4. Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) [Up to Month 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Salehi Retina Institute Inc.Huntington BeachCaliforniaUnited States92647
    2California Eye Specialists Medical Group, Inc.PasadenaCaliforniaUnited States91107
    3Retinal Consultants Medical GroupSacramentoCaliforniaUnited States95825
    4Retina Consultants of Southern Colorado, P.C.Colorado SpringsColoradoUnited States80909
    5Retina Associates, LtdElmhurstIllinoisUnited States60126
    6University Retina and macula Associates, PCOak ForestIllinoisUnited States60452
    7Cumberland Valley Retina ConsultantsHagerstownMarylandUnited States21740
    8Sierra Eye AssociatesRenoNevadaUnited States89502
    9Retina Vitreous Surgeons of Central New York, PCLiverpoolNew YorkUnited States13088
    10Tulsa Retina ConsultantsTulsaOklahomaUnited States74114
    11Eye Care SpecialistsKingstonPennsylvaniaUnited States18704
    12Austin Research Center of RetinaAustinTexasUnited States78705
    13Valley Retina Institute, P.A.McAllenTexasUnited States78503
    14Medical Center Ophthalmology AssociatesSan AntonioTexasUnited States78240
    15Retina Center of TexasSouthlakeTexasUnited States76092
    16Strategic Clinical Research GroupWillow ParkTexasUnited States76087

    Sponsors and Collaborators

    • Oxurion

    Investigators

    • Study Director: Clinical Department, Oxurion

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oxurion
    ClinicalTrials.gov Identifier:
    NCT05063734
    Other Study ID Numbers:
    • THR-687-002
    • 2020-000362-42
    First Posted:
    Oct 1, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2021