Clinical trial NCT01521559: Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
Official title: A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]) in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Branch Retinal Vein Occlusion
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2012-01-30
Enrollment: 183
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 III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.


Eligibility criteria: Inclusion Criteria:

The following inclusion criteria include, but are not limited to:

1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
3. Provide signed informed consent

Exclusion Criteria:

The following exclusion criteria include, but are not limited to:

1. Current bilateral manifestation of BRVO
2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
3. Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)
4. Uncontrolled diabetes mellitus (DM)
5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
6. Use of periocular corticosteroids in the study eye within 3 months before day 1
7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
8. Previous administration of systemic anti-angiogenic medications
9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye

Primary outcomes:
measure: Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Change From Baseline to Week 24 in BCVA Score - LOCF
timeFrame: Baseline to Week 24
measure: Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
timeFrame: Baseline to week 24
measure: Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Fort Myers
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Baltimore (2 locations)
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Boston (2 locations)
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Florissant
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Teaneck
country: United States
state: New Jersey
city: Orchard Park
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Kingston
country: United States
state: Pennsylvania
city: West Mifflin
country: United States
state: Pennsylvania
city: Florence
country: United States
state: South Carolina
city: Ladson
country: United States
state: South Carolina
city: West Columbia
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Harlingen
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Mississauga
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Urayasu-shi
country: Japan
state: Chiba
city: Amagasaki
country: Japan
state: Hyogo
city: Kagoshima-shi
country: Japan
state: Kagoshima
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Fukushima
country: Japan
city: Kyoto
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD009510. doi: 10.1002/14651858.CD009510.pub3.