Trial Outcomes & Findings for Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO) (NCT NCT01521559)

Last Updated: 2014-11-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

183 participants

Primary outcome timeframe

Baseline to week 24

Results posted on

2014-11-13

Participant Flow

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.

Of 281 participants who were screened for inclusion in the study, 183 were enrolled (started) and 183 received treatment.

Participant milestones

Participant milestones
Measure	Macular Laser Photocoagulation Treatment (Control) Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received 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.	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) Participants received 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 could receive laser rescue at week 36.
Overall Study STARTED	92	91
Overall Study Completed Week 24	83	85
Overall Study Completed Week 52	77	73
Overall Study COMPLETED	77	73
Overall Study NOT COMPLETED	15	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Macular Laser Photocoagulation Treatment (Control) Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received 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.	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) Participants received 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 could receive laser rescue at week 36.
Overall Study Adverse Event	0	4
Overall Study Death	1	0
Overall Study Withdrawal by Subject	9	11
Overall Study Lost to Follow-up	3	1
Overall Study Protocol Violation	1	0
Overall Study Other	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Macular Laser Photocoagulation Treatment (Control) n=90 Participants Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received 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.	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) n=91 Participants Participants received 2 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 could receive laser rescue at week 36.	Total n=181 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 11.37 • n=5 Participants	67.0 years STANDARD_DEVIATION 10.41 • n=7 Participants	65.5 years STANDARD_DEVIATION 10.98 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	47 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	44 Participants n=7 Participants	98 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to week 24

Population: FAS

Outcome measures

Outcome measures
Measure	Macular Laser Photocoagulation Treatment (Control) n=90 Participants Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) n=91 Participants Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF	24 participants	48 participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: FAS

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.

Outcome measures

Outcome measures
Measure	Macular Laser Photocoagulation Treatment (Control) n=90 Participants Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) n=91 Participants Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
Change From Baseline to Week 24 in BCVA Score - LOCF	6.9 letters correctly read Standard Deviation 12.91	17.0 letters correctly read Standard Deviation 11.88

SECONDARY outcome

Timeframe: Baseline to week 24

Population: FAS

CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).

Outcome measures

Outcome measures
Measure	Macular Laser Photocoagulation Treatment (Control) n=90 Participants Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) n=91 Participants Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF	-128.0 microns Standard Deviation 195.02	-280.5 microns Standard Deviation 189.7

SECONDARY outcome

Timeframe: Baseline to week 24

Population: FAS

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.

Outcome measures

Outcome measures
Measure	Macular Laser Photocoagulation Treatment (Control) n=87 Participants Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) n=88 Participants Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF	6.3 scores on a scale Standard Deviation 12.34	7.7 scores on a scale Standard Deviation 11.08

Adverse Events

Macular Laser Photocoagulation Treatment (Control)

Serious events: 10 serious events

Other events: 30 other events

Deaths: 0 deaths

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

Serious events: 13 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Macular Laser Photocoagulation Treatment (Control) n=92 participants at risk Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received 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.	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) n=91 participants at risk Participants received 2 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 could receive laser rescue at week 36.
Investigations Blood pressure increased	5.4% 5/92 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).	4.4% 4/91 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).
Infections and infestations Bronchitis	2.2% 2/92 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).	6.6% 6/91 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).
Eye disorders Conjunctival haemorrhage	15.2% 14/92 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).	24.2% 22/91 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).
Eye disorders Eye irritation	1.1% 1/92 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).	7.7% 7/91 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).
Eye disorders Eye pain	7.6% 7/92 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).	5.5% 5/91 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).
Vascular disorders Hypertension	16.3% 15/92 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).	9.9% 9/91 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).
Infections and infestations Nasopharyngitis	8.7% 8/92 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).	8.8% 8/91 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).
Infections and infestations Urinary tract infection	7.6% 7/92 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).	3.3% 3/91 • Through Week 52 (end of study) The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated).

Additional Information

Clinical Trials Administrator

Regeneron

Phone: 914 847 5385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Without the prior written agreement of the Sponsor, the Institution (I) shall not publish, submit or present for publication, directly or indirectly, any Manuscript (M) prior to publication of an article in a peer-reviewed scientific journal summarizing data generated by all Study centers, unless no such article is so published before the first anniversary of the finalization of the clinical study report, in which case the (I) may publish or submit for publication a (M) without further delay.
Publication restrictions are in place

Restriction type: OTHER