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Trial record 1 of 1 for:    vgfte-rvo-1027
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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)

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ClinicalTrials.gov Identifier: NCT01521559
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 26, 2012
First Posted Date  ICMJE January 30, 2012
Results First Submitted Date  ICMJE November 5, 2014
Results First Posted Date  ICMJE November 13, 2014
Last Update Posted Date November 13, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2014)
Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF [ Time Frame: Baseline to week 24 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
Proportion of patients who gain at least 15 letters in BCVA [ Time Frame: At week 24 from baseline ]
BCVA (Best Corrected Visual Acuity)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2014)
  • Change From Baseline to Week 24 in BCVA Score - LOCF [ Time Frame: Baseline to Week 24 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
  • Change in BCVA score [ Time Frame: At week 24 from baseline ]
  • Change in CRT [ Time Frame: At week 24 from baseline ]
    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 ]
    NEI VFQ-25 (National Eye Institute Visual Function Questionnaire - 25)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Branch Retinal Vein Occlusion
Intervention  ICMJE
  • Procedure: Macular Laser Photocoagulation
  • Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Publications * 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:CD009510. doi: 10.1002/14651858.CD009510.pub3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2013)
183
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2012)
180
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01521559
Other Study ID Numbers  ICMJE VGFTe-RVO-1027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Regeneron Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Regeneron Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP