NCT Number: NCT01997164
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)
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).
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Beverly Hills, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
- For patients with AMD:
- 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
- Men or women ≥50 years and older
- For patients with DME:
- Patients with clinically significant DME with central involvement (≥300 μm in the central subfield on spectral domain OCT)
- Men or women ≥18 years and older
Key Exclusion Criteria:
- For patients with neovascular AMD:
- Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye
- Evidence of diabetic retinopathy (DR) or DME in either eye
- For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye
- Prior IAI in either eye
- 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
- Any prior treatment with angiopoietin inhibitors
- Any prior systemic (IV) anti-VEGF administration
- History of vitreoretinal surgery in the study eye
- Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit
- 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).
Treatment and study plan
REGN910
DrugIntravitreal Aflibercept Injection (IAI)
DrugOther names: EYLEA®
Primary outcomes
-
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Change from baseline to week 24
Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910
Secondary outcomes
-
Pharmacokinetic (PK) profile
Time frame: Baseline to week 24
PK profile may include, but is not limited to, the following:
- AUCall - area under the curve (AUC) computed from time zero to the time of the last concentration
- AUCall/Dose - AUCall-to-dose ratio
- AUClast - AUC computed from time zero to the time of the last positive concentration
- AUClast/Dose - AUClast-to-dose ratio
- Cmax - the peak concentration
- Cmax/Dose - Cmax-to-dose ratio
-
Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3
Time frame: Baseline to week 24
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Nov 27, 2013
- Registry last updated
- Jan 12, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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