A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)
Study Status: Enrolling
What is the purpose of this study?
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called VRDN-001 in reducing proptosis, diplopia, and inflammation in patients with Graves’s disease associated with thyroid eye disease (TED).
What will I have to do if I take part in this study?
The main procedures in the study include:
- Study drug VRDN-001 and/or placebo administration via intravenous infusions.
- Evaluation for changes in eye protrusion (exophthalmometry), measurement of how far apart your eyelids are open (lid retraction), facial structure (orbital & facial Magnetic Resonance Imaging [MRI] or CT scan [Computerize Tomography]) and facial aesthetics (facial & gaze photography).
- Evaluation for changes in your eye condition and vision [slit-lamp eye exam with a microscope (bio-microscopy), measuring of your visual acuity, and exam of the back of the eye (fundoscopy).
- Evaluation for changes in double vision (diplopia) and eye pressure (intraocular pressure).
- Evaluation for changes in hearing (hearing tests).
- Evaluation for changes in your assessment of your thyroid eye disease and its effect on your day-to-day living.
- Laboratory blood sample testing on multiple study visit days
Is this the right trial for me?
If you are over the age of 18 years and have a clinical diagnosis of Graves’ disease associated with active thyroid eye disease with symptoms of proptosis and at least one of the following: lid retraction, diplopia, spontaneous retrobulbar pain or pain on eye movement, swelling of the conjunctiva, eyelids, or plica, or redness of eyelids or plica, you might be eligible for this study.
For additional information
- Principal Investigator: Adam de la Garza, MD
- Trial Coordinators: Alcides Fernandez Filho, MD, and Afif Martini
- ClinicalTrials.gov