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

Stopped early · Phase 2

Conditions studied: Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema

In brief

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).

Key facts

Study ID

NCT05063734

Run by

Oxurion

People needed

16

Starts

2021-08-27

Expected to finish

2022-06-29

Last updated by the study team

2023-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Ganglion Medical Center — Pécs, Hungary
• Salehi Retina Institute Inc. — Huntington Beach, California, United States
• California Eye Specialists Medical Group, Inc. — Pasadena, California, United States
• Retinal Consultants Medical Group — Sacramento, California, United States
• Retina Consultants of Southern Colorado, P.C. — Colorado Springs, Colorado, United States
• Retina Associates, Ltd — Elmhurst, Illinois, United States
• University Retina and macula Associates, PC — Oak Forest, Illinois, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Retina Vitreous Surgeons of Central New York, PC — Liverpool, New York, United States
• Tulsa Retina Consultants — Tulsa, Oklahoma, United States
• Eye Care Specialists — Kingston, Pennsylvania, United States
• Tennessee Retina, PC — Nashville, Tennessee, United States
• Austin Research Center of Retina — Austin, Texas, United States
• Retina Consultants of Texas — Katy, Texas, United States
• Valley Retina Institute, P.A. — McAllen, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Retina Center of Texas — Southlake, Texas, United States
• Strategic Clinical Research Group — Willow Park, Texas, United States
• Eye Clinic Dr Krista Turman — Tallinn, Estonia
• Silmalaser OU — Tallinn, Estonia
• Szegedi Tudományegyetem — Szeged, Hungary
• Pauls Stradins Clinical University Hospital — Riga, Latvia
• Riga East Clinical University Hospital — Riga, Latvia
• Vilnius University Hospital Santaros klinikos — Vilnius, Lithuania

Full record on ClinicalTrials.gov

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