Clinical trial NCT00789477: DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
Official title: A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2008-11-11
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

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 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

Primary outcomes:
measure: Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
timeFrame: At week 24
Secondary outcomes:
measure: Change in BCVA From Baseline to Week 52 - LOCF
timeFrame: At week 52
measure: Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF
timeFrame: At week 24 and week 52
measure: Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF
timeFrame: At week 24 and week 52
measure: Number of Focal Laser Treatments
timeFrame: Week 1 to week 48
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Hamden
country: United States
state: Connecticut
city: New London
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Indianapolis
country: United States
state: Indiana
city: Bangor
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: New Brunswick
country: United States
state: New Jersey
city: Northfield
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: West Columbia
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Wien
country: Austria
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: