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