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)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Branch Retinal Vein Occlusion

Treatments: Procedure: Macular Laser Photocoagulation; Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521559

VGFTe-RVO-1027

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 2 patient groups

Macular Laser Photocoagulation Treatment (Control)

Sham Comparator group

Description:

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.

Treatment:

Procedure: Macular Laser Photocoagulation

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4

Experimental group

Description:

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.

Treatment:

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