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)

Diabetic Macular Edema Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997164
• Other study ID #: R910-3-OD-1403
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2013
• Last updated: January 11, 2016
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• REGN910-3

• REGN910

• Intravitreal Aflibercept Injection (IAI)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)	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	Change from baseline to week 24	Yes
Secondary	Pharmacokinetic (PK) profile	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	Baseline to week 24	No
Secondary	Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3		Baseline to week 24	No