A Study of VV-14305 for the Treatment of Thyroid Eye Disease

Inclusion criteria

• Must be 18 to 80 years of age (inclusive) at Screening.
• Body Mass Index (BMI) of 19 to 34 kg/m2 (inclusive).
• Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid state).
• Best Corrected Visual Acuity (BCVA) score of 20/60 or better at Screening with no history of deterioration noted in the 3 months prior to Screening.
• Must be willing and able to cease product use prior to VV-14305 (or sham) peribulbar injection if using non-steroidal anti-inflammatory drug (NSAIDs), medications or any herbal supplements, vitamins, or multivitamins with antiplatelet/anticoagulant properties.
• The study eye and the fellow eye must fall within the pre-defined degree of proptosis and clinical activity score (CAS) as measured at Screening.
• Participants must be diagnosed with TED prior to Screening and be diagnosed with Graves' disease and progressive moderate to severe TED at Screening.

Exclusion criteria

• History of serious ocular condition(s) other than TED, including but not limited to uveitis, dry age-related macular degeneration (AMD), and wet AMD; Other orbital or ophthalmic diseases, including inflammatory conditions, optic neuropathy, tumors, glaucoma with visual field defect or visual field loss, that in the opinion of the Investigator and/or Medical Monitor is clinically significant.
• Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or would make the participant an unsafe study candidate.
• Diagnosed with diabetes (HbA1c ≥6.5%).
• History of malignancy requiring chemotherapy and/or radiation in the 12 months prior to Screening, except for successfully treated nonmelanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia, and localized prostate cancer.
• Known allergy or condition that would contraindicate the use of required study medications.
• Any Screening assessment or laboratory value that, in the opinion of the Investigator and/or Medical Monitor, is clinically significant and renders the subject not suitable for study participation.
• Any vaccination or planned vaccination 30 days prior to dosing, 4 weeks post dosing or during period of immunosuppression.
• Participant requires or, in the opinion of the Investigator, is likely to require immediate surgical ophthalmological/orbital intervention or irradiation of either eye; Has had any prior surgery for TED including orbital decompression, strabismus surgery and any eyelid surgery on either eye.
• Prior participation in other gene therapy, investigational drug, biologic or device clinical trials within 30 days prior to Screening.