Male or female, 18 years of age or older.
Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.
Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.
In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.
Intra-Ocular Pressure (IOP) is under control (i.e., IOP ≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.
Willing and able to return for all study visits.
Able to meet the extensive post-op evaluation regimen.
Understands and signs the informed consent form.

NCT02348918_inc_T1
Person
Male
NCT02348918_inc_T2
Person
female
NCT02348918_inc_T3
Value
18 years or older
NCT02348918_inc_T4
Person
age
NCT02348918_inc_T5
Condition
diabetic macular edema (DME)
NCT02348918_inc_T6
Qualifier
clinically significant
NCT02348918_inc_T7
Measurement
central subfield thickness
NCT02348918_inc_T8
Value
≥ 350µm
NCT02348918_inc_T9
Procedure
spectral domain OCT
NCT02348918_inc_T10
Measurement
Best corrected visual acuity (BCVA)
NCT02348918_inc_T11
Value
20/50 to 20/320 ETDRS equivalent
NCT02348918_inc_T12
Value
65 letters to 23 letters
NCT02348918_inc_T13
Qualifier
in the study eye
NCT02348918_inc_T15
Observation
Treatment naïve
NCT02348918_inc_T16
Negation
no
NCT02348918_inc_T17
Temporal
previous
NCT02348918_inc_T18
Procedure
anti-VEGF treatment
NCT02348918_inc_T19
Qualifier
in the study eye
NCT02348918_inc_T20
Negation
no
NCT02348918_inc_T21
Procedure
anti-VEGF treatment
NCT02348918_inc_T22
Temporal
in the 45 days prior to study enrollment
NCT02348918_inc_T23
Reference_point
study enrollment
NCT02348918_inc_T24
Scope
no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment
NCT02348918_inc_T26
Qualifier
significant
NCT02348918_inc_T27
Condition
intraretinal fluid
NCT02348918_inc_T28
Qualifier
with room for improvement
NCT02348918_inc_T30
Condition
macular edema
NCT02348918_inc_T31
Condition
BCVA
NCT02348918_inc_T32
Scope
macular edema and BCVA
NCT02348918_inc_T33
Measurement
Intra-Ocular Pressure (IOP)
NCT02348918_inc_T34
Value
under control
NCT02348918_inc_T35
Measurement
IOP
NCT02348918_inc_T36
Value
≤ 25 mm
NCT02348918_inc_T37
Qualifier
in the study eye
NCT02348918_inc_T38
Drug
IOP lowering drops
NCT02348918_inc_T39
Negation
not
NCT02348918_inc_T40
Qualifier
study eye
NCT02348918_inc_T41
Scope
IOP ≤ 25 mm in the study eye
NCT02348918_inc_T42
Scope
Intra-Ocular Pressure (IOP) is under control