TABLE 3.

Summary of Changes From Baseline at 12 Months in Patients Receiving Encapsulated Cell Intraocular Implants for Retinitis Pigmentosa

Endpoint	CNTF3		CNTF4
	Low-Dose Implant/Sham	High-Dose Implant/Sham	Low-Dose Implant/Sham	High-Dose Implant/Sham
Change in best-corrected visual acuity
Month 12
Mean (SD)	−2.9 ± 11.3/−2.3 ± 12	−1.3 ± 9.6/−3.2 ± 10.5	−0.5 ± 5.0/0.5 ± 4.7	0.7 ± 4.1/1.0 ± 4.6
Range	−48-11/−47-11	−25-14/−45-15	−16-7/−15-6	−7–12/−9–11
P value	.650	.275	.497	.646
Change in total macular volume (mm3)
Month 12
Mean (SD)	0.09 ± 0.23/−0.05 ± 0.17	0.23 ± 0.58/−0.02 ± 0.18	0.22 ± 0.21/−0.05 ± 0.38	0.43 ± 0.37/−0.05 ± 0.27
Range	−0.4-0.4/−0.5-0.2	−1.2–2.2/−0.5-0.3	−0.2–0.7/−1.2-0.8	−0.3–1.7/−1.3-0.8
P value	.148	<.001	.001	<.001
Change in electroretinogram (μV) (geometric means)
Month 12
Mean (SD)	1.10 ± 1.5/0.99 ± 1.48	0.78 ± 1.5/0.89 ± 1.73	1.03 ± 1.62/0.99 ± 1.48	0.79 ± 1.52/0.87 ± 1.73
Range	0.5–2.9/0.6–2.3	0.2–1.4/0.1–2.1	0.4–2.9/0.6–2.3	0.2–1.4/0.1–2.1
P value	.347	.129	.776	.242
Change in Humphrey visual field sensitivity (dB)
Month 12
Mean (SD)	4.1 ± 109.5/4.7 ± 101.4	−98.4 ± 165.3/−14 ± 101.5	1.4 ± 174.6/16.8 ± 165.4	−164.3 ± 114.6/−67.1 ± 104.2
Range	−172–282/−213–374	−487-242/−294-286	−265–354/−191–423	−489–95/−322–152
P value	.97	.001	.137	<.001

CNTF3 = ciliary neurotrophic factor for late-stage retinitis pigmentosa study 3; CNTF4 = ciliary neurotrophic factor for early-stage retinitis pigmentosa study 4.