NCT05063734

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 diabetes-mellitus

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_2 diabetes-mellitus

Geographic Reach
5 countries

25 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 18, 2023

Completed
Last Updated

August 18, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

September 8, 2021

Results QC Date

June 29, 2023

Last Update Submit

July 25, 2023

Conditions

Diabetes MellitusDiabetic RetinopathyDiabetic Macular Edema

Outcome Measures

Primary Outcomes (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 Outcomes (4)

  • 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

  • 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

  • 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)

Study Arms (6)

Part A, THR-687 1.2 mg

EXPERIMENTAL
Drug: THR-687 dose level 1

Part A, THR-687 2.0mg

EXPERIMENTAL
Drug: THR-687 dose level 2

Part B, treatment naïve subjects, THR-687 selected dose level

EXPERIMENTAL

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

Part B, treatment naïve subjects, aflibercept 2.0mg

ACTIVE COMPARATOR
Drug: Aflibercept

Part B, previously treated subjects, THR-687 selected dose level

EXPERIMENTAL

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

Part B, previously treated subjects, aflibercept 2.0mg

ACTIVE COMPARATOR
Drug: Aflibercept

Interventions

THR-687 dose level 1DRUG

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

Part A, THR-687 1.2 mg
THR-687 dose level 2DRUG

3 intravitreal injections of THR-687 dose level 2, 1 month apart

Part A, THR-687 2.0mg
THR-687 selected dose levelDRUG

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.

Part B, previously treated subjects, THR-687 selected dose levelPart B, treatment naïve subjects, THR-687 selected dose level
AfliberceptDRUG

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.

Also known as: Eylea®
Part B, previously treated subjects, aflibercept 2.0mgPart B, treatment naïve subjects, aflibercept 2.0mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Salehi Retina Institute Inc.

Huntington Beach, California, 92647, United States

Location

California Eye Specialists Medical Group, Inc.

Pasadena, California, 91107, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

Retina Consultants of Southern Colorado, P.C.

Colorado Springs, Colorado, 80909, United States

Location

Retina Associates, Ltd

Elmhurst, Illinois, 60126, United States

Location

University Retina and macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Retina Vitreous Surgeons of Central New York, PC

Liverpool, New York, 13088, United States

Location

Tulsa Retina Consultants

Tulsa, Oklahoma, 74114, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

Location

Austin Research Center of Retina

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Valley Retina Institute, P.A.

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retina Center of Texas

Southlake, Texas, 76092, United States

Location

Strategic Clinical Research Group

Willow Park, Texas, 76087, United States

Location

Eye Clinic Dr Krista Turman

Tallinn, 11314, Estonia

Location

Silmalaser OU

Tallinn, 11412, Estonia

Location

Ganglion Medical Center

Pécs, 7621, Hungary

Location

Szegedi Tudományegyetem

Szeged, 6720, Hungary

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Riga East Clinical University Hospital

Riga, LV-1006, Latvia

Location

Vilnius University Hospital Santaros klinikos

Vilnius, LT-08661, Lithuania

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Limitations and Caveats

Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B

Results Point of Contact

Title
Clinical Department
Organization
Oxurion
info@oxurion.com
+32 16 75 13 10

Study Officials

  • Clinical Department

    Oxurion

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

October 1, 2021

Study Start

August 27, 2021

Primary Completion

June 29, 2022

Study Completion

June 29, 2022

Last Updated

August 18, 2023

Results First Posted

August 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)LA(2)LI(1)HU(2)US(18)