Study to Assess the Clinical Efficacy and Safety of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI], Also Commercially Known as EYLEA™) in Patients With Branch Retinal Vein Occlusion (BRVO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01521559
First received: January 26, 2012
Last updated: July 10, 2014
Last verified: May 2014
  Purpose

This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of VEGF Trap-Eye compared to laser treatment in patients with macular edema secondary to BRVO.


Condition Intervention Phase
Branch Retinal Vein Occlusion
Drug: VEGF Trap-Eye
Device: Laser Treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients who gain at least 15 letters in BCVA [ Time Frame: At week 24 from baseline ] [ Designated as safety issue: No ]
    BCVA (Best Corrected Visual Acuity)


Secondary Outcome Measures:
  • Change in BCVA score [ Time Frame: At week 24 from baseline ] [ Designated as safety issue: No ]
  • Change in CRT [ Time Frame: At week 24 from baseline ] [ Designated as safety issue: No ]
    CRT (central retinal thickness) as assessed by optical coherence tomography (OCT)

  • Change in total score of NEI VFQ-25 [ Time Frame: At week 24 from baseline ] [ Designated as safety issue: No ]
    NEI VFQ-25 (National Eye Institute Visual Function Questionnaire - 25)


Enrollment: 183
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment regimen 1 Drug: VEGF Trap-Eye
VEGF Trap-Eye injections per treatment regimen 1
Other Names:
  • Intravitreal Aflibercept Injection [IAI]
  • EYLEA™
Active Comparator: Treatment regimen 2 Device: Laser Treatment
Laser treatment at day 1 per treatment regimen 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521559

  Show 56 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01521559     History of Changes
Other Study ID Numbers: VGFTe-RVO-1027
Study First Received: January 26, 2012
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014