Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa

Table 2

Characteristics of study population in the randomized clinical trials included in the systematic review.

Randomized clinical trial (country)	Population	Number of patients randomized per group (experimental/control)	Mean age of patients per group (years) (experimental/control)	Gender per group (experimental/control)
Chatzinoff et al. 1968 (USA) [28]	71 patients with RP	36/35	NA	NA
Newsome et al. 1987 (USA) [32]	32 patients with RP	17/15	43.7/39.8	10M, 7F/13M, 2F
Berson et al. 1993 [8] (USA)	601 patients with typical RP	Group A = 146, group E = 155, group A + E = 151, trace group = 149	Group A = 32.5, group E = 31.5, group A + E = 32.3, trace group = 32.2	373M, 228F
Sibulesky et al. 1999 [33] (USA)	121 patients with typical RP	Group A = 115, trace group = 106	NA	NA
Vingolo et al. 1998 [6] (ITA)	48 patients with typical RP	24/24	33.6/32.8	14M, 10F/16M, 8F
Wheaton et al. 2003 [34] and Hoffman et al. 2004 [30] (USA)	44 X-linked RP patients	23/21	14.9/18	23M/21M
Berson et al. 2004 (USA) [27]	208 patients with typical RP	105/103	37.8/36	50M, 55F/56M, 47F
Berson et al. 2004a (USA) [26]; Subgroup analysis of Berson et al. 2004 [27]	208 patients with typical RP	Vitamin A prior to entry: 75/68; No vitamin A prior to entry: 30/35	Vitamin A prior to entry: 38.1/36.8; No vitamin A prior to entry: 36.9/34.5	Vitamin A prior to entry: 37F, 38M/32F, 38M; No vitamin A prior to entry: 18F, 12M/17F, 18M
Bahrami et al. 2006 [9] (USA)	34 patients with typical RP	16/18 crossover design	52.4/46.4	11F, 5M/10F, 8M
Merin et al. 2008 [14] (Israel)	17 patients with RP	17 patients randomized per eye	38	10M, 7F
Vingolo et al. 2008 [5] (ITA)	88 patients with RP	44/44	35/35.5	21M, 23F/21M, 23F
Berson et al. 2010 [10] (USA)	225 nonsmoker patients with typical RP	110/115	40/38	58M, 42F/52M, 63F
Nakazawa et al. 2011 [13] (Japan)	33 patients with RP	19/14	52/48	9M, 10F/7M, 7F
Rotenstreich et al. 2013 [11] (Israel)	29 patients with RP	16 Dunaliella-first group/18 placebo-first group	46.7	21M, 8F
Birch et al. 2013 [15] (USA)	65 patients with late-stage RP (CNTF3 study), and 68 patients with early-stage RP (CNTF4 study)	Low dose: 42; High dose: 91; Sham: 133 (fellow eye)	Low dose: 38; High dose: 41	Low dose: 24M, 18F; High dose: 43M, 48F
Hoffman et al. 2014 [29] (USA) and Hughbanks-Wheaton et al. 2014 [31]	60 X-linked RP patients	27/33	16.1/14.9	27M/33M
Kumar et al. 2014 [12] (India)	30 patients with typical RP	15/15	30/31	10M, 5F/12M, 3F

RP: Retinitis pigmentosa.
CNTF: Ciliary neurotrophic factor.
M: Male.
F: Female.
Subgroup analysis of Berson 2004 study: patients taking vitamin A prior to entry versus patients not taking vitamin A prior to entry.