Trial Outcomes & Findings for Repeated Eye Injections of Aflibercept for Treatment of Wet Age Related Macular Degeneration (NCT NCT01773954)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Baseline to Week 52

Results posted on

2018-05-02

Participant milestones
Measure	Intravitreal Aflibercept Intravitreal aflibercept on treat and extend schedule
Overall Study STARTED	40
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	9

Withdrawal data not reported

Repeated Eye Injections of Aflibercept for Treatment of Wet Age Related Macular Degeneration

Baseline characteristics by cohort
Measure	Intravitreal Aflibercept n=40 Participants Intravitreal aflibercept on treat and extend schedule
Age, Continuous	81.3 years STANDARD_DEVIATION 7.4 • n=99 Participants
Sex: Female, Male Female	23 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants
Region of Enrollment United States	40 participants n=99 Participants

Timeframe: Baseline to Week 52

Outcome measures
Measure	Intravitreal Aflibercept n=40 Participants Intravitreal aflibercept on treat and extend schedule
Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score	7.2 letters Interval 2.9 to 11.6

Timeframe: Baseline to Week 52

Outcome measures
Measure	Intravitreal Aflibercept n=40 Participants Intravitreal aflibercept on treat and extend schedule
Change in Total Thickness at the Foveal Center Point on OCT	-143 micrometers Interval -187.0 to -99.0

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events
Measure	Intravitreal Aflibercept n=40 participants at risk Intravitreal aflibercept on treat and extend schedule
Cardiac disorders Fatal MI	2.5% 1/40 • 2 years
Eye disorders Endophthalmitis	2.5% 1/40 • 2 years

Adverse event data not reported

Mid Atlantic Retina

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