A Phase 3 interventional study of Macular Laser Photocoagulation and Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Branch Retinal Vein Occlusion, sponsored by Regeneron Pharmaceuticals. Completed at 56 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-13.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.
This study's enrollment of 183 is above the median of 49 across 211 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
The following inclusion criteria include, but are not limited to:
Exclusion Criteria:
The following exclusion criteria include, but are not limited to:
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.
Procedure: Macular Laser Photocoagulation
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.
Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
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.
Time frame: Baseline to week 24
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.
Time frame: Baseline to Week 24
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).
Time frame: Baseline to week 24
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.
Time frame: Baseline to week 24
Participants with macular edema secondary to branch retinal vein occlusion (BRVO) involving the center of the macula in the study eye were eligible to participate in the study.
| Milestone | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Started | 92 | 91 |
| Completed week 24 | 83 | 85 |
| Completed week 52 | 77 | 73 |
| Completed | 77 | 73 |
| Not completed | 15 | 18 |
| Withdrew: Adverse event | 0 | 4 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Withdrawal by subject | 9 | 11 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Other | 1 | 2 |
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.
| participants | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF | 24 | 48 |
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.
| letters correctly read | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Change From Baseline to Week 24 in BCVA Score - LOCF | 6.9 ± 12.91 | 17.0 ± 11.88 |
CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).
| microns | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF | -128.0 ± 195.02 | -280.5 ± 189.7 |
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.
| scores on a scale | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF | 6.3 ± 12.34 | 7.7 ± 11.08 |
Collected over Through Week 52 (end of study). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Macular Laser Photocoagulation Treatment (Control) | — | 10/92 (10.9%) | 30/92 (32.6%) |
| Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | — | 13/91 (14.3%) | 25/91 (27.5%) |
| Event | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/92 | 2/91 |
| PneumoniaInfections and infestations | 1/92 | 2/91 |
| DehydrationMetabolism and nutrition disorders | 2/92 | 0/91 |
| Atrial fibrillationCardiac disorders | 0/92 | 1/91 |
| Atrioventricular block second degreeCardiac disorders | 0/92 | 1/91 |
| BradycardiaCardiac disorders | 0/92 | 1/91 |
| Breast cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/92 | 1/91 |
| CardiomyopathyCardiac disorders | 0/92 | 1/91 |
| Cataract traumaticInjury, poisoning and procedural complications | 0/92 | 1/91 |
| Chest painGeneral disorders | 0/92 | 1/91 |
| Event | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Conjunctival haemorrhageEye disorders | 14/92 | 22/91 |
| HypertensionVascular disorders | 15/92 | 9/91 |
| NasopharyngitisInfections and infestations | 8/92 | 8/91 |
| Eye irritationEye disorders | 1/92 | 7/91 |
| Eye painEye disorders | 7/92 | 5/91 |
| Urinary tract infectionInfections and infestations | 7/92 | 3/91 |
| BronchitisInfections and infestations | 2/92 | 6/91 |
| Blood pressure increasedInvestigations | 5/92 | 4/91 |
Full analysis set (FAS): All enrolled subjects who received any investigational product, had a baseline best corrected visual acuity (BCVA) assessment, and at least 1 post-baseline BCVA assessment.
| Age, Continuous(years) | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | Total |
|---|---|---|---|
| Mean | 63.9 ± 11.37 | 67.0 ± 10.41 | 65.5 ± 10.98 |
| Sex: Female, Male(Participants) | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | Total |
|---|---|---|---|
| Female | 36 | 47 | 83 |
| Male | 54 | 44 | 98 |
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals