Effect of topical isopropyl unoprostone on macular atrophy progression in eyes with exudative age-related macular degeneration.
BACKGROUND
To evaluate the efficacy and safety of topical isopropyl unoprostone (IU) in treating macular atrophy in age-related macular degeneration (AMD) patients.


METHODS
Fifty-two AMD patients with macular atrophy were included and randomly assigned (1:1) to the treatment (topical 0.15% IU) or placebo group. Subjects used study eye drops 3 times a day for 54 weeks. The macular atrophy was documented on fundus autofluorescence photographs and measured using RegionFinder. The enlargement rate of macular atrophy and the changes in visual acuity were examined statistically between baseline and 54 weeks.


RESULTS
Forty-eight subjects were included in the analyses because 4 subjects withdrew from the study. The differences between the IU and placebo groups in mean and median area of macular atrophy were not statistically significant at baseline. The baseline median lesion size of macular atrophy was 2.33 mm in the IU group and 1.63 mm in the placebo group (P = 0.51). The intergroup difference in the enlargement ratio of macular atrophy (21 ± 15% in the IU group and 111 ± 96% in the placebo group) was statistically significant (P < 0.001). Additionally, visual acuity tended to improve over baseline in the IU group. No serious adverse events were observed.


CONCLUSIONS
Topical IU therapy is safe and effective for treating macular atrophy in AMD patients.
Department of Ophthalmology, Kagawa University Faculty of Medicine, Kagawa Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto Department of Ophthalmology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Chieko
C
Shiragami
Masahiro
M
Miyake
Atsushi
A
Fujiwara
Yuki
Y
Morizane
Akitaka
A
Tsujikawa
Ayana
A
Yamashita
Fumio
F
Shiraga
D000287:Administration, Topical; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015237:Dinoprost / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D008268:Macular Degeneration / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D014792:Visual Acuity
D000959:Antihypertensive Agents; C072630:isopropyl unoprostone; D015237:Dinoprost