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Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO) (VIBRANT)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01521559
First received: January 26, 2012
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Branch Retinal Vein Occlusion
Procedure: Macular Laser Photocoagulation
Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
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
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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.


Secondary Outcome Measures:
  • Change From Baseline to Week 24 in BCVA Score - LOCF [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.

  • Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).

  • Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.


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
Sham Comparator: Macular Laser Photocoagulation Treatment (Control)
Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
Procedure: Macular Laser Photocoagulation
Experimental: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36.
Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

  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
Bayer
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
Results First Received: November 5, 2014
Last Updated: November 5, 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
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis

ClinicalTrials.gov processed this record on November 25, 2014