Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration
Conditions
Brief 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).
Interventions
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) profile | 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 | Baseline to week 24 | — |
Countries
United States
Outcome results
None listed