Clinical Trial: Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Masked, Randomized, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema

Brief Summary: The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.

Detailed Summary:
Sponsor: Regeneron Pharmaceuticals

Current Primary Outcome: Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and Week 52 ]

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.


Original Primary Outcome: Change from baseline of BCVA in ETDRS letter score [ Time Frame: week 100 ]

Current Secondary Outcome:

  • Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ]
  • Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ]
  • Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ]
    Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
  • Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF [ Time Frame: Baseline and Week 52 ]
  • Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ]
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
  • Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF [ Time Frame: Baseline and Week 52 ]
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.


Original Secondary Outcome:

  • Change in retinal thickness from baseline [ Time Frame: week 100 ]
  • Proportion of patients who gain a threshold change from baseline in visual acuity [ Time Frame: week 100 ]
  • Change in quality of life subscale 1 from baseline [ Time Frame: week 100 ]
  • Change in quality of life subscale 2 from baseline [ Time Frame: week 100 ]


Information By: Regeneron Pharmaceuticals

Dates:
Date Received: May 27, 2011
Date Started: May 2011
Date Completion:
Last Updated: April 25, 2016
Last Verified: April 2016