Clinical Trial: Efficacy and Safety of Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of Three Different Treatment Regimens of 2 mg Aflibercept Administered by Intravi

Brief Summary: To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to subjects with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Change in ETDRS BCVA (Early Treatment Diabetic Retinopathy Study - best corrected visual acuity) letter score for the study eye from baseline to week 52 [ Time Frame: From baseline to week 52 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in ETDRS BCVA letter score for the study eye from baseline to week 100 [ Time Frame: From baseline to week 100 ]
  • Change from baseline in CRT (central retinal thickness) in the study eye from baseline to week 52 [ Time Frame: From baseline to week 52 ]
  • Change from baseline in CRT in the study eye from baseline to week 100 [ Time Frame: From baseline to week 100 ]
  • Proportion of subjects who gained 10 or more letters from baseline to week 52 [ Time Frame: From baseline to week 52 ]
  • Proportion of subjects who gained 10 or more letters from baseline to week 100 [ Time Frame: From baseline to week 100 ]
  • Proportion of subjects who gained 15 or more letters from baseline to week 52 [ Time Frame: From baseline to week 52 ]
  • Proportion of subjects who gained 15 or more letters from baseline to week 100 [ Time Frame: From baseline to week 100 ]
  • Proportion of subjects who lost 30 or more letters from baseline to week 52 [ Time Frame: From baseline to week 52 ]
  • Proportion of subjects who lost 30 or more letters from baseline to week 100 [ Time Frame: From baseline to week 100 ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 100 weeks ]
  • Vital signs [ Time Frame: Up to 100 weeks ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: June 28, 2016
Date Started: November 16, 2016
Date Completion: August 5, 2019
Last Updated: May 12, 2017
Last Verified: May 2017