Table 4. Adverse Events Through 2 Years.
| No. (%) | ||
|---|---|---|
| Aflibercept (n = 100) |
Vitrectomy and panretinal photocoagulation (n = 105) |
|
| Ocular adverse events occurring in study eyes: participants with ≥1 event | ||
| Cataract extraction or visually significant cataract on clinical examination (eyes with natural lens only) | (n = 75) 37 (49) |
(n = 81) 36 (44) |
| Visually significant cataract | (n = 75) 34 (45) |
(n = 81) 35 (43) |
| Cataract extraction | (n = 75)a 23 (31) |
(n = 81) 22 (27) |
| Adverse intraocular pressure event | 23 (23) | 25 (24) |
| Increase in intraocular pressure ≥10 mm Hg from baseline | 16 (16) | 17 (16) |
| Intraocular pressure ≥30 mm Hg at any visit | 8 (8) | 10 (10) |
| Initiation of medication not in use at baseline to lower intraocular pressure | 14 (14) | 16 (15) |
| Glaucoma procedure | 0 | 2 (2) |
| Retinal detachment | 23 (23) | 15 (14) |
| Traction retinal detachment | 22 (22) | 14 (13) |
| Rhegmatogenous retinal detachment | 4 (4) | 5 (5) |
| Ocular inflammation | 6 (6) | 4 (4) |
| Neovascularization of the iris | 2 (2) | 5 (5) |
| Retinal tear (without detachment) | 3 (3) | 2 (2) |
| Endophthalmitis | 1 (1) | 2 (2) |
| Neovascular glaucoma | 1 (1) | 2 (2) |
| Systemic adverse events: participants with ≥1 event | ||
| Serious adverse event | 42 (42) | 43 (41) |
| Hospitalization | 39 (39) | 41 (39) |
| Death | 6 (6) | 3 (3) |
| Vascular events defined by Antiplatelet Trialists’ Collaboration criteria | ||
| Any event | 8 (8) | 7 (7) |
| Death due to vascular or unknown cause | 5 (5) | 3 (3) |
| Nonfatal stroke | 2 (2) | 2 (2) |
| Nonfatal myocardial infarction | 1 (1) | 2 (2) |
a
Among the 75 eyes with natural lens (ie, phakic eyes) in the initial aflibercept group at baseline, 27 underwent vitrectomy during follow-up. Of the 23 eyes that underwent cataract extraction, 9 had cataract extraction and no vitrectomy during follow-up, 3 had cataract extraction before undergoing vitrectomy (ie, these eyes were phakic at baseline but pseudophakic at time of first vitrectomy), and 11 had cataract extraction after their first vitrectomy.