REGN910-3 DME

Active Clinical Trials // Feb 14 2017

sponsored by Regeneron

A randomized, double-masked, active-controlled phase-2 study of the efficacy, safety, and tolerability of repeated doses of intravitrial REGN910-3 in patients with Diabetic Macular Edema

Principal Investigator: Mihai Mititelu

Study Coordinator: Angie Adler

Study Objective: 

The primary objective of the study is to compare the efficacy of IVT-administered REGN910-3 compared to Eylea in improving Best corrected Visual Acuity in patients with Diabetic Macular Edema.

Study Eligibility Criteria:

Inclusion Criteria:

A patient must meet the following criteria to be eligible for inclusion in the study:

  1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have clinically significant DME with central involvement (≥300 μm in the central subfield on SD-OCT) in the study eye
  1. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.
  1. Willing and able to comply with clinic visits and study-related procedures.
  2. Provide signed informed consent.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

  1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye
  2. IVT anti-VEGF (IAI, bevacizumab, ranibizumab, or pegaptanib sodium) in the study eye within 12 weeks of the screening visit
  1. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
  1. Any history of macular hole of stage 2 and above in the study eye
  2. Only 1 functional eye, even if that eye was otherwise eligible for the study (eg, BCVA of counting fingers or less in the eye with worse vision)
  1. Ocular conditions with poorer prognosis in the fellow eye
  2. Any prior treatment with angiopoietin inhibitors
  3. Any prior systemic (IV) anti-VEGF administration
  4. History of vitreoretinal surgery in the study eye
  5. Previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening
  1. Intraocular pressure (IOP) ≥25 mm Hg in the study eye
  2. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye at the time of screening/randomization
  1. Any intraocular inflammation/infection in either eye within 3 months of the screening visit
  1. Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
  1. Inability to obtain photographs, FA or SD-OCT, eg, due to media opacity, allergy to fluorescein dye or lack of venous access
  1. Uncontrolled diabetes mellitus in the opinion of the investigator
  2. Uncontrolled blood pressure (defined as systolic >160 mm Hg or diastolic >95 mm Hg while patient is sitting)
  1. History of cerebrovascular accident or myocardial infarction within 180 days of screening visit
  1. Renal failure, dialysis, or history of renal transplant
  2. Known sensitivity to any of the compounds of the study formulation

 

For more information please call Angie Adler at 608-265-7557