Table 4.

Frequency of Macular Edema at 4 Or 16 Weeks

	Definite Central-involved Macular Edema at 4 Weeks		Definite Central-involved Macular Edema at 4 OR 16 Weeks**		Definite Central-Involved OR Progression to Definite NON- Central involved Macular Edema† at 16 Week
	Proportion (%)	95% Confidence Interval of Proportion	Proportion (%)	95% Confidence Interval of Proportion	Proportion (%)	95% Confidence Interval of Proportion
	N = 259		N = 266		N = 261
Baseline OCT Thickness
A. No central involved DME & No non-central  involved DME*	1/15 (7%)	0.2%-32%	1/17 (6%)	0.2-29%	2/17 (12%)	1-36%
B. No central involved DME & Definite/  Possible non-central involved DME*	6/94 (6%)	2%-13%	11/97 (11%)	6-19%	12/97 (12%)	7-21%
C. Possible central involved DME and  Definite/possible non-central involved  DME*	15/150 (10%)	6-16%	24/152 (16%)	10-23%	22/147 (15%)	10-22%
Baseline OCT Thickness and History of DME Treatment
A. No DME	1/15 (7%)	0.2%-32%	1/17 (6%)	0.2-29%	2/17 (12%)	1-36%
B. Any DME And No History of DME  Treatment	7/139 (5%)	2-10%	11/144 (8%)	4-13%	8/140 (6%)	3-11%
C. Any DME With History of DME Treatment	14/105 (13%)	7-21%	24/105 (23%)	15-32%	26/104 (25%)	17-34%
Recent DME Treatment Only	0/4 (0%)		0/4 (0%)		0/4 (0%)
Recent and Old DME Treatment	6/18 (33%)		7/18 (39%)		7/18 (39%)
Old DME Treatment Only	8/83 (10%)		17/83 (20%)		19/82 (23%)

OCT= Optical Coherence Tomography, DME=diabetic macular edema

^*Five eyes, originally classified in the possible central-involved DME and no non-central involved DME group, were individually examined by the protocol chair due to small numbers in the subgroup and were reclassified into the no central or non-central involved DME (N = 1), no central-involved DME and definite/possible non-central involved DME (N = 1) and the possible central-involved and definite/possible non-central involved DME (N = 3) groups respectively in the analysis

^†Includes only eyes with gradable non-central subfields at baseline and 16 weeks.