Table 10.

Major Ocular Adverse Events during Follow-Up

	Sham+ Focal/Grid/PRP Laser	Ranibizumab+ Focal/Grid/PRP Laser	Triamcinolone+ Focal/Grid/PRP Laser
Up to 14 week visit	N = 133	N = 116 # injections = 227	N = 115 # injections = 115
Endophthalmitis, no. (%)*	0	1 (0.9%)	0
Ocular vascular event, no. (%)	0	0	0
Retinal detachment†, no. (%)	4 (3%)	1 (1%)	1 (1%)
Vitrectomy‡, no. (%)	1 (1%)	0	1 (1%)
Vitreous hemorrhage, no. (%)	16 (12%)	6 (5%)	7 (6%)
Elevated IOP/glaucoma, no. (%)
Increase ≥10 mmHg from baseline	3 (2%)	0	20 (17%)
IOP ≥30 mmHg	2 (2%)	0	5 (4%)
Initiation of IOP-lowering medication at any visit||	2 (2%)	0	2 (2%)
Number of eyes meeting one or more of the above	3 (2%)	0	20 (17%)
Glaucoma surgery	0	0	0
Cataract Surgery
Phakic at baseline	N = 120	N = 93	N = 105
No. (%) with cataract surgery	0	0	0
After 14 to 56 week visit	N = 131	N = 111	N = 112
Endophthalmitis, no. (%)	0	0	0
Ocular vascular event, no. (%)	0	0	0
Retinal detachment†, no. (%)	4 (3%)	5 (5%)	1 (1%)
Vitrectomy‡, no. (%)	17 (13%)	8 (7%)	7 (6%)
Vitreous hemorrhage, no. (%)	28 (21%)	25 (23%)	20 (18%)
Elevated IOP/glaucoma, no. (%)
Increase ≥10 mmHg from baseline	6 (5%)	6 (5%)	10 (9%)
IOP ≥30 mmHg	4 (3%)	4 (4%)	4 (4%)
Initiation of IOP-lowering medication at any visit after the 14-week visit	7 (5%)	5 (5%)	17 (15%)
Number of eyes meeting one or more of the above	11 (8%)	7 (6%)	20 (18%)
IOP-lowering medication at 56 visit	3 (2%)	4 (4%)	9 (9%)
Glaucoma surgery §	0	1 (1%)	1 (1%)
Cataract Surgery
Phakic at 14 weeks	N = 119	N = 91	N = 102
No. (%) with cataract surgery	2 (2%)	3 (3%)	6 (6%)

PRP=panretinal photocoagulation.

^*One case related to study drug injection in the ranibizumab+focal/grid/PRP laser group.

^†All had tractional detachment except two eyes had unspecified retinal detachment (one by 14-week visit and one after 14-week visit)

^‡All were for PDR

^||Excludes eyes with intraocular pressure (IOP) lowering medications at baseline.

^§Includes 2 Ahmed valve (neovascular glaucoma).