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
Overview
- Phase
- Phase 3
- Intervention
- Macular Laser Photocoagulation
- Conditions
- Diabetic Macular Edema
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 466
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Macular Laser Photocoagulation Treatment (Control)
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.
Intervention: Macular Laser Photocoagulation
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Intervention: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Intervention: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)