Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2014
End Date:October 2015

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An Open-Label, Dose-Escalation Study of the Safety and Tolerability of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular AMD or DME

The primary objective of the study is to investigate the safety and tolerability of
intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related
macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).


Key Inclusion Criteria:

1. For patients with AMD:

1. Active subfoveal choroidal neovascularization (CNV) secondary to AMD, including
juxtafoveal lesions that affect the fovea as evidenced by FA or OCT in the study
eye, as determined by the investigator

2. Men or women ≥50 years and older

2. For patients with DME:

1. Patients with clinically significant DME with central involvement (≥300 μm in
the central subfield on spectral domain OCT)

2. Men or women ≥18 years and older

Key Exclusion Criteria:

1. For patients with neovascular AMD:

1. Evidence of choroidal neovascularization (CNV) due to any cause other than AMD
in either eye

2. Evidence of diabetic retinopathy (DR) or DME in either eye

2. For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either
eye

3. Prior IAI in either eye

4. IVT bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of
day 1 or an AE with any of these previous treatments that would preclude
administration of drug in this study

5. Any prior treatment with angiopoietin inhibitors

6. Any prior systemic (IV) anti-VEGF administration

7. History of vitreoretinal surgery in the study eye

8. Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye
within 3 months of the screening visit

9. Previous use of intraocular or periocular corticosteroids in the study eye within 4
months of screening

(The inclusion/ exclusion criteria provided above are not intended to contain all
considerations relevant to a subject's potential participation in this clinical trial).
We found this trial at
5
sites
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from
Boston, MA
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Abilene, TX
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Beverly Hills, California 90211
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from
Beverly Hills, CA
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West Columbia, South Carolina 29169
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from
West Columbia, SC
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from
Winter Haven, FL
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