Prostaglandin F2-Alpha Eye Drops (Bimatoprost) in Graves' Orbitopathy: A Randomized Controlled Double-Masked Crossover Trial (BIMA Trial)

Mohd Shazli Draman*, Daniel S. Morris, Sam Evans, Anjana Haridas, Julie Pell, Rosemary Greenwood, Chris Foy, Peter Taylor, Pakinee Pooprasert, Ilaria Muller, Lei Zhang, Carol Lane, Onyebuchi Okosieme, Marian Ludgate, Colin Dayan

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)

3 Citations (Scopus)
53 Downloads (Pure)

Abstract

Background: Previous in vitro experiments have demonstrated that prostaglandin F2-alpha (PF ) reduced proliferation and adipogenesis in a murine cell line and human orbital fibroblasts derived from subjects with inactive Graves' orbitopathy (GO). The objective of this study was to determine if the PGF analogue bimatoprost is effective at reducing proptosis in this population. Methods: A randomized controlled double-masked crossover trial was conducted in a single tertiary care academic medical center. Patients with long-standing, inactive GO but persistent proptosis (>20 mm in at least one eye) were recruited. Allowing for a 15% dropout rate, 31 patients (26 females) were randomized in order to identify a treatment effect of 2.0 mm (p = 0.05; power 0.88). Following informed consent, participants were randomized to receive bimatoprost or placebo for three months, after which they underwent a two-month washout before switching to the opposite treatment. The primary outcome was the change in exophthalmometry readings over the two three-month treatment periods. Results: The mean exophthalmometer at baseline was 23.6 mm (range 20.0-30.5 mm), and the mean age of the patients was 55 years (range 28-74 years). The median duration of GO was 7.6 years (interquartile range 3.6-12.3 years). The majority were still suffering from diplopia (61.3%) with bilateral involvement (61.3%). Using multi-level modeling adjusted for baseline, period, and carry-over, bimatoprost resulted in a -0.17 mm (reduction) exophthalmometry change ([confidence interval -0.67 to +0.32]; p = 0.490). There was a mean change in intraocular pressure of -2.7 mmHg ([confidence interval -4.0 to -1.4]; p = 0.0070). One patient showed periorbital fat atrophy on treatment, which resolved on stopping treatment. Independent analysis of proptosis by photographic images (all subjects) and subgroup analysis on monocular disease (n = 12) did not show any apparent benefit. Conclusions: In inactive GO, bimatoprost treatment over a three-month period does not result in an improvement in proptosis.

Original languageEnglish
Pages (from-to)563-572
Number of pages10
JournalThyroid
Volume29
Issue number4
Early online date1 Apr 2019
DOIs
Publication statusPublished - 9 Apr 2019

Keywords

  • Bimatoprost
  • fat atrophy
  • Graves' orbitopathy
  • prostaglandin F2a
  • thyroid eye disease

Fingerprint Dive into the research topics of 'Prostaglandin F2-Alpha Eye Drops (Bimatoprost) in Graves' Orbitopathy: A Randomized Controlled Double-Masked Crossover Trial (BIMA Trial)'. Together they form a unique fingerprint.

Cite this