Phase 3
N=183
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
Bottom Line
View on ClinicalTrials.gov: NCT01521559 ↗Enrolled (actual)
183
Serious AEs
12.6%
Results posted
Nov 2014
Primary outcome: Primary: Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF — 24; 48 participants — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Macular Laser Photocoagulation (Procedure); Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF |
24; 48 | 0.0003 sig |
| SECONDARY Change From Baseline to Week 24 in BCVA Score - LOCF |
6.9; 17.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF |
-128.0; -280.5 | <0.0001 sig |
| SECONDARY Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF |
6.3; 7.7 | 0.0833 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01521559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.