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

Branch Retinal Vein Occlusion Clinical Trial

— VIBRANT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521559
• Other study ID #: VGFTe-RVO-1027
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2012
• Last updated: November 5, 2014
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2014
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Procedure:
• Macular Laser Photocoagulation

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Bayer

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF	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.	Baseline to week 24	No
Secondary	Change From Baseline to Week 24 in BCVA Score - LOCF	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.	Baseline to Week 24	No
Secondary	Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF	CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).	Baseline to week 24	No
Secondary	Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF	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.	Baseline to week 24	No