Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

  • STATUS
    Recruiting
  • End date
    May 9, 2023
  • participants needed
    640
  • sponsor
    Regeneron Pharmaceuticals
Updated on 8 September 2021
swelling
retinopathy
diabetic retinopathy
corrected visual acuity
visual impairment
aflibercept
diabetic macular edema
diabetic eye disease

Summary

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

The secondary objectives of the study are as follows:

  • To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
  • To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Details
Condition NIDDM, Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Prevention, Diabetic Macular Edema, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 1 diabetes mellitus, type 2 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Aflibercept, High-Dose aflibercept
Clinical Study IdentifierNCT04429503
SponsorRegeneron Pharmaceuticals
Last Modified on8 September 2021

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