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

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Procedure: Macular Laser Photocoagulation; Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)

• Registration Number: NCT01363440
• Lead Sponsor: Regeneron Pharmaceuticals

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 Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-01
• Primary Completion: 2013-01
• Disposition First Submitted: 2014-02-11
• Disposition First Submitted QC: 2014-02-11
• Disposition First Posted: 2014-03-13
• Results First Submitted: 2014-08-28
• Study Completion: 2014-11
• Results First Submitted QC: 2015-04-02
• Results First Posted: 2015-04-20
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 466

Inclusion Criteria

The following is an abbreviated list of inclusion criteria:

• Adults ≥ 18 years with type 1 or 2 diabetes mellitus
• Decrease in vision determined to be primarily the result of DME in the study eye
• BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria

The following is an abbreviated list of exclusion criteria:

• Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1
• Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1
• Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
• Active proliferative diabetic retinopathy (PDR) in the study eye
• Uncontrolled diabetes mellitus
• Only 1 functional eye even if that eye is otherwise eligible for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macular Laser Photocoagulation Treatment (Control)	Macular Laser Photocoagulation	Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4	Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)	Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8	Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)	Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.

Primary Outcome Measures

Name	Time	Method
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)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF	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	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 National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF	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.
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF	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	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.
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF	Baseline and Week 52