TABLE 2.
Adverse Events at 12 Months in Patients Receiving Encapsulated Cell Intraocular Implants for Retinitis Pigmentosa
| Adverse Events/Eye Disorders | CNTF3
|
CNTF4
|
||
|---|---|---|---|---|
| Low Dose (n = 22) | High Dose (n = 43) | Low Dose (n = 20) | High Dose (n = 48) | |
| Intraocular pressure increasea | 0 (0.0%) | 1 (2.3%) | 0 (0.0%) | 1 (2.1%) |
| Eye hemorrhageb | 2 (9.1%) | 0 (0.0%) | 1 (5%) | 0 (0.0%) |
| Photopsia | 0 (0.0%) | 1 (2.3%) | 0 (0.0%) | 4 (8.3%) |
| Miosis | 1 (4.5%) | 11 (25.6%) | 0 (0.0%) | 15 (31.3%) |
| Cataractc | 1 (4.5%) | 2 (4.7%) | 0 (0.0%) | 2 (4.2%) |
| Choroidal neovascularization | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Wound leaks or erosion | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Endophthalmitis | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Implant extrusion | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Retinal detachment | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
CNTF3 = ciliary neurotrophic factor for late-stage retinitis pigmentosa study 3; CNTF4 = ciliary neurotrophic factor for early-stage retinitis pigmentosa study 4.
a
Intraocular pressure increase (24–31 mm Hg) usually lasted a few days to a few weeks and pressure returned to normal at the next scheduled visit without medical intervention.
b
Related to the surgical wound and recovered with no sequelae within 10 days.
c
Worsening of a pre-existing cataract (mild).