Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age-Related Macular Degeneration
Diabetic Macular Edema
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility 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/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Change from baseline to week 24
Secondary outcomes:
measure: Pharmacokinetic (PK) profile
timeFrame: Baseline to week 24
measure: Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Winter Haven
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: West Columbia
country: United States
state: South Carolina
city: Abilene
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: