Closed Oculoplastics Trials


A Multicenter, Double-Masked, Placebo-Controlled, Efficacy and Safety Study of RV 001, an Insulin-like Growth Factor-1 Receptor (ICF-1R) Antagonist Antibody (Fully Human), Administered Every 3 Weeks By Intravenous (IV) Infusion in Patients Suffering From Active Thyroid Eye Disease (TED)

PI: Brent Hayek, MD
Coordinator: Judy Brower
Status: Completed.

General Summary: This study is to determine whether RV 001, given by IV every 3 weeks for 6 months (total of 8 treatments), is safe and effective in the treatment of patients suffering from active thyroid eye disease. Patients will continue to be followed for 1 year after treatment has ended.

Inclusion Criteria:
- Age 18 - 75 years
- Thyroid eye disease diagnosed in the past 9 months
- No medical therapy or surgery for TED except oral steroids if the maximum cumulative dose is less than 1000 mg. There must be at least 6 weeks between the last administration of steroids and study randomization.

Exclusion Criteria:
- Decreased visual acuity due to optic neuropathy
- Corneal decompensation that is not managable medically
- Any study drugs in the past 60 days
- Any past treatment with rituximab (Rituxan or MabThera)
- Past orbital irradiation
- Malignant condition in past 12 months (successfully treated basal call of skin does not exclude)
- Pregnant or lactating women
- Poorly controlled diabetes
- Treatment with oral or intravenous (IV) steroids within the previous 3 months except oral steroids for the treatment of TED with a cumulative dose less than 1000 mg providing there is a 6 week washout before study randomization (topical steroids for skin condition are not excluded)

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updated: 07-03-2013; 03-12-2014; 09-21-2015; 11/30/2016

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