Table 16.
Major Ocular Adverse Events During 2 Years of Follow Up
| Sham + Prompt Laser N = 293 | Ranibizumab + Prompt Laser N = 187 # injections = 1833 | Ranibizumab + Deferred Laser N = 188 # injections = 2140 | Triamcinolone + Prompt Laser N = 186 # injections = 685 | |
|---|---|---|---|---|
| Endophthalmitis, no. (%)* | 1 (<1%) | 2 (1%) | 2 (1%) | 0 |
| Pseudoendophthalmitis, no. (%)† | 1 (<1%) | 0 | 0 | 1 (1%) |
| Ocular vascular event, no. (%)‡ | 1 (<1%) | 1 (1%) | 1 (1%) | 3 (2%) |
| Retinal detachment, no. (%) | 0 | 0 | 1 (1%)§ | 0 |
| Vitrectomy, no. (%) | 15 (5%) | 4 (2%) | 7 (4%) | 2 (1%) |
| Vitreous hemorrhage, no. (%) | 27 (9%) | 6 (3%) | 8 (4%) | 7 (4%) |
| Elevated intraocular pressure/glaucoma, no. (%) | ||||
| Increase ≥10 mmHg from baseline | 22 (8%) | 16 (9%) | 11 (6%) | 78 (42%) |
| IOP ≥30 mmHg | 8 (3%) | 3 (2%) | 6 (3%) | 51 (27%) |
| Initiation of IOP-lowering medication at any visit∥ | 16 (5%) | 9 (5%) | 6 (3%) | 53 (28%) |
| Number of eyes meeting one or more of the above | 32 (11%) | 20 (11%) | 14 (7%) | 93 (50%) |
| Glaucoma surgerya | 1 (<1%) | 1 (1%) | 0 | 2 (1%) |
| Cataract surgery | ||||
| Phakic at baseline | N = 192 | N = 131 | N = 134 | N = 124 |
| No. (%) with cataract surgery | 23 (12%) | 16 (12%) | 17 (13%) | 68 (55%) |
IOP = intraocular pressure
One case unrelated to study drug injection (following cataract extraction) in the sham+prompt laser group; 1 case related to study drug injection and 1 case unrelated to injection (following cataract surgery) in the ranibizumab+prompt laser group; 2 cases related to study drug injection in the ranibizumab+deferred laser group. The 3 cases related to study drug injection in the ranibizumab groups are 0.08% of ranibizumab study drug injections given. Endophthalmitis was defined as any patient having an intravitreal or anterior chamber tap for presumed endophthalmitis or treated for infectious endophthalmitis regardless of whether a tap was performed or whether a culture is positive.
One case unrelated to the study drug injection (vitreous opacity with hypopyon) and one case related to study drug injection in the triamcinolone group. Pseudoendophthalmitis was defined based on investigator diagnosis and patient not tapped or treated for infectious endophthalmitis.
Includes 2 central retinal vein occlusions and 4 branch retinal vein occlusions.
Includes 1 traction retinal detachment with proliferative diabetic retinopathy and prior panretinal photocoagulation at baseline. Visual acuity had remained stable (within 5 letters) of the baseline visual acuity letter score of 66 (20/50) while ranibizumab was given every 4 weeks through the 24-week visit when focal/grid laser also was applied. Ranibizumab again was given at the 28-week visit and five weeks later, sudden vision loss was reported and a table top detachment involving the central macula was noted at an unscheduled visit with a visual acuity letter score of 48 (20/125). Vitrectomy surgery was delayed for several weeks because of other medical problems; following surgery, the visual acuity letter score remained 0 (<20/800).
Excludes eyes with IOP lowering medications at baseline.
Includes 2 filter and 2 cilliary body destruction.