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NCT Number: 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)

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.

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Key information

Conditions

Branch Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

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

  • Current bilateral manifestation of BRVO
  • Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
  • 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)
  • Uncontrolled diabetes mellitus (DM)
  • Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
  • Use of periocular corticosteroids in the study eye within 3 months before day 1
  • Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
  • Previous administration of systemic anti-angiogenic medications
  • Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye

Treatment and study plan

Macular Laser Photocoagulation

Procedure

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Acronym: VIBRANT

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 30, 2012
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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