Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease

Table 4

Summary of Expert Panel’s COA (full analysis set, LOCF). The Expert Panel defined worsening as any of the following (thresholds determined from clinical experience and reading centers’ assessment of control subjects): Roth 28 error scores >295 right eye, >271 left; MD change of −2 dB confirmed by a later test; field defect clusters of 3 locations at or 2 at ; ERG parameter change scores (log₁₀ differences from log₁₀ baseline values) <2.56 times standard deviation of repeatability; fundus changes from “absent” to “obvious” for any finding; acuity loss ≥10 letters; pupil change from normal to abnormal; IOP >22 mmHg. Prespecified subgroup analyses of the COA results are shown in Table 5.

Parameters	After 2 years on treatment		After 1 year on treatment
	Pramipexole	Ropinirole	Pramipexole	Ropinirole
Worse from baseline, n (%)	34 (29.6)	33 (27.7)	28 (24.3)	21 (17.6)
Estimated RR for pramipexole compared with ropinirole	1.07 (95% CI 0.71, 1.60)		Not calculated for 1-year data
Number with clinically significant ophthalmologic change, n (%)	17 (14.8)	20 (16.8)	14 (12.2)	15 (12.6)
Number of subjects with study drug-related change, n (%)
Definitely not	1 (0.9)	4 (3.4)	1 (0.9)	2 (1.7)
Unlikely	6 (5.2)	6 (5.0)	5 (4.3)	6 (5.0)
Possibly	10 (8.7)	10 (8.4)	8 (7.0)	7 (5.9)
Probably	0	0	0	0
Definitely	0	0	0	0

18 subjects per group had responses carried forward.
15 subjects had responses carried forward.
Eight subjects were assessed as “worse from baseline” in 2-year data based on responses carried forward (2 subjects in pramipexole group and 6 in ropinirole group).
Four subjects were assessed as “worse from baseline” in 1-year data based on responses carried forward (1 subject in pramipexole group and 3 subjects in ropinirole group).
There were 2 subjects for whom the Expert Panel could not assess clinical significance due to unreliable visual field testing in 2-year data.
The Expert Panel was able to assess clinical significance for all subjects in 1-year data.
CI: confidence interval; COA: comprehensive ophthalmology assessment; IOP: intraocular pressure; LOCF: last observation carried forward; MD: mean deviation; RR: relative risk.