A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)

Completed · Phase 1

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

In brief

This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.

Key facts

Study ID

NCT03511898

Run by

ThromboGenics

People needed

12

Starts

2018-05-18

Expected to finish

2019-05-22

Last updated by the study team

2019-06-13

Who can join

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

You may qualify if…

• Male or female aged 18 years or older
• Type 1 or type 2 Diabetes Mellitus
• Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye
• Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
• Written informed consent obtained from the subject prior to screening procedures

You may not qualify if…

• Macular edema due to causes other than DME
• Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, 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 a change in central subfield thickness in the study eye
• Previous confounding treatments / procedures, or their planned / expected use during the study period
• Presence of neovascularization at the disc (NVD) in the study eye
• Uncontrolled glaucoma in the study eye
• Any active ocular / intra-ocular infection or inflammation in either eye
• Poorly controlled Diabetes Mellitus
• Uncontrolled hypertension

Where it is running

• Retina Consultants of Arizona — Phoenix, Arizona, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Mid Atlantic Retina — Huntingdon Valley, Pennsylvania, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Retinal Research Center, PLLC — Austin, Texas, United States
• Retina Consultants of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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