A Study to Evaluate THR-149 Treatment for Diabetic Macula... | NCT04527107

Studies
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

NCT04527107

Sponsor

Oxurion

Status

Completed

Last Update Posted

Nov 27, 2023Actual

Enrollment

135Actual

Phase

Phase 2

Conditions

Diabetes Mellitus
Diabetic Retinopathy
Diabetic Macular Edema

Interventions

THR-149 dose level 1
THR-149 dose level 2
THR-149 dose level 3
THR-149 0.13mg
THR-149 0.13mg + aflibercept 2mg
aflibercept 2mg + THR-149 0.13mg
Aflibercept 2mg

Countries

United States
Czechia
France
Germany
Italy
Slovakia
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2019-001506-17	EudraCT Number

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2020Actual

Primary Completion Date

Sep 28, 2023Actual

Completion Date

Nov 22, 2023Actual

First Submitted Date

Aug 21, 2020

First Submission Date that Met QC Criteria

Aug 21, 2020

First Posted Date

Aug 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2023

Last Update Posted Date

Nov 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
THR-149 dose level 1	Experimental	Drug: THR-149 dose level 1
THR-149 dose level 2	Experimental	Drug: THR-149 dose level 2
THR-149 dose level 3	Experimental	Drug: THR-149 dose level 3
THR-149 + sham	Experimental	Drug: THR-149 0.13mg
THR-149 + aflibercept flip-over	Experimental	Drug: THR-149 0.13mg + aflibercept 2mg
Aflibercept + THR-149 flip-over	Active Comparator	Drug: aflibercept 2mg + THR-149 0.13mg
Aflibercept + sham	Active Comparator	Drug: Aflibercept 2mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
THR-149 dose level 1	Drug	3 intravitreal injections of THR-149 dose level 1, 1 month apart	THR-149 dose level 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study		At Month 3

Secondary Outcomes

Measure	Description	Time Frame
Mean change in BCVA ETDRS letter score from Baseline, by study visit		Up to Month 6
Mean change in central subfield thickness (CST) from Baseline, by study visit		Up to Month 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key 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 ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
BCVA ETDRS letter score ≥ 34 in the fellow eye

Key Exclusion Criteria:

Macular edema due to causes other than DME in the study eye
Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
Previous confounding medications / interventions, or their planned administration
Presence of neovascularisation at the disc in the study eye
Presence of iris neovascularisation in the study eye
Uncontrolled glaucoma in the study eye
Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
Untreated Diabetes Mellitus
Glycated haemoglobin A (HbA1c) > 12%
Uncontrolled hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Retinal Research Institute, LLC		Phoenix	Arizona	85053	United States
Retina Associates

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D048909	Diabetes Complications