Phase 2 N=221 Randomized Quadruple-blind Treatment

DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT00789477 ↗

Enrolled (actual)

221

Serious AEs

25.1%

Results posted

Sep 2014

Primary outcome: Primary: Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF) — 2.5; 8.6; 11.4; 8.5 letters correctly read

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Laser Photocoagulation (Procedure); Intravitreal Aflibercept Injection (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Regeneron Pharmaceuticals
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)	2.5; 8.6; 11.4; 8.5; 10.3	—
SECONDARY Change in BCVA From Baseline to Week 52 - LOCF	-1.3; 11.0; 13.1; 9.7; 12.0	—
SECONDARY Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF	9; 15; 14; 7; 12; 5	—
SECONDARY Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF	-67.9; -144.6; -194.5; -127.3; -153.3; -58.4	—
SECONDARY Number of Focal Laser Treatments	2.5; 0.8; 0.5; 0.8; 0.7	—

Summary

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Eligibility Criteria

Inclusion Criteria

Patients with clinically significant DME with central involvement
Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye

Exclusion Criteria

History of vitreoretinal surgery in the study eye
Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
Uncontrolled diabetes mellitus
Uncontrolled hypertension defined as systolic > 180mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
Ocular disorders in the study eye, other than DME, that may confound interpretation of study results

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00789477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.