Status:
COMPLETED
DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Bayer
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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). Approximatel...
Detailed Description
Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00789477
Start Date
December 1 2008
End Date
September 1 2010
Last Update
September 9 2014
Active Locations (47)
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1
Artesia, California, United States, 90701
2
Beverly Hills, California, United States, 90211
3
Mountain View, California, United States, 94040
4
Pasadena, California, United States, 91105