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

Sponsor

Oxurion (Industry)

Overall Status

Terminated

CT.gov ID

NCT05063734

Collaborator

(none)

Enrollment

Locations

Arms

10.1

Actual Duration (Months)

0.6

Patients Per Site

0.1

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 Disease	Intervention/Treatment	Phase
Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema	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

Actual Enrollment :

16 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

Actual Primary Completion Date :

Jun 29, 2022

Actual Study Completion Date :

Jun 29, 2022

Arms and Interventions

Arm	Intervention/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

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

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 Month 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Salehi Retina Institute Inc.	Huntington Beach	California	United States	92647
2	California Eye Specialists Medical Group, Inc.	Pasadena	California	United States	91107
3	Retinal Consultants Medical Group	Sacramento	California	United States	95825
4	Retina Consultants of Southern Colorado, P.C.	Colorado Springs	Colorado	United States	80909
5	Retina Associates, Ltd	Elmhurst	Illinois	United States	60126
6	University Retina and macula Associates, PC	Oak Forest	Illinois	United States	60452
7	Cumberland Valley Retina Consultants	Hagerstown	Maryland	United States	21740
8	Sierra Eye Associates	Reno	Nevada	United States	89502
9	Retina Vitreous Surgeons of Central New York, PC	Liverpool	New York	United States	13088
10	Tulsa Retina Consultants	Tulsa	Oklahoma	United States	74114
11	Eye Care Specialists	Kingston	Pennsylvania	United States	18704
12	Tennessee Retina, PC	Nashville	Tennessee	United States	37203
13	Austin Research Center of Retina	Austin	Texas	United States	78705
14	Retina Consultants of Texas	Katy	Texas	United States	77494
15	Valley Retina Institute, P.A.	McAllen	Texas	United States	78503
16	Medical Center Ophthalmology Associates	San Antonio	Texas	United States	78240
17	Retina Center of Texas	Southlake	Texas	United States	76092
18	Strategic Clinical Research Group	Willow Park	Texas	United States	76087
19	Eye Clinic Dr Krista Turman	Tallinn		Estonia	11314
20	Silmalaser OU	Tallinn		Estonia	11412
21	Ganglion Medical Center	Pécs		Hungary	7621
22	Szegedi Tudományegyetem	Szeged		Hungary	6720
23	Pauls Stradins Clinical University Hospital	Riga		Latvia	LV-1002
24	Riga East Clinical University Hospital	Riga		Latvia	LV-1006
25	Vilnius University Hospital Santaros klinikos	Vilnius		Lithuania	LT-08661

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:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022