REGN910-3- AMD

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 neovascular age-related macular degeneration

Principal Investigator: Mihai Mititelu

Study Coordinator: Angie Adler

Study Objective:

The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in improving best-corrected visual acuity (BCVA) in patients with age-related macular degeneration (AMD)

Study Eligibility Criteria:

Inclusion Criteria

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

  1. Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as assessed by a central reading center
  2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.
  3. Willing and able to comply with clinic visits and study-related procedures.
  4. Provide signed informed consent.

Exclusion Criteria

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

  1. Evidence of CNV due to any cause other than AMD in either eye
  2. Prior IVT anti-VEGF (IAI, ranibizumab, bevacizumab or pegaptanib sodium) in the study eye
  3. Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
  4. Any history of macular hole of stage 2 and above in the study eye
  5. 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)
  6. Ocular conditions with poorer prognosis in the fellow eye
  7. Any prior treatment with angiopoietin inhibitors
  8. Any prior systemic (IV) anti-VEGF administration
  9. History of vitreoretinal surgery in the study eye
  10. Previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening
  11. Intraocular pressure (IOP) ≥25 mm Hg in the study eye
  12. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye at the time of screening/randomization
  13. Any intraocular inflammation/infection in either eye within 3 months of the screening visit
  14. Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
  15. Inability to obtain photographs, FA or SD-OCT, eg, due to media opacity, allergy to fluorescein dye or lack of venous access
  16. Uncontrolled diabetes mellitus in the opinion of the investigator
  17. Uncontrolled blood pressure (defined as systolic >160 mm Hg or diastolic >95 mm Hg while patient is sitting)
  18. History of cerebrovascular accident or myocardial infarction within 180 days of screening visit
  19. Renal failure, dialysis, or history of renal transplant
  20. Known sensitivity to any of the compounds of the study formulation
  21. Pregnant or breast-feeding women

 

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