Clinical Trial: Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Comparison of the Effect of Bromocriptine and Pentoxifylline in Mild to Moderate Autoimmune Ophthalmopathy. A Randomized, Controlled, Single Blind, Clinical Trial.

Brief Summary:

Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present, the treatment is directed to identify vision threatening which requires aggressive intervention, usually with glucocorticoids. For mild cases the treatment is limited to the normalization of hyperthyroidism and support measures. Preliminary data show that pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine and pentoxifylline on the clinical course and quality of life of patients with mild to moderate ophthalmopathy associated to Graves´disease.

Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution, and naive to treatment were randomized to receive treatment during 12 months with either 1) bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was applied.


Detailed Summary:
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Current Primary Outcome: Proptosis [ Time Frame: One year ]

Left and right eye proptosis by exophthalmometry


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical activity score [ Time Frame: One year ]
    Clinical activity score for Graves' ophthalmopathy
  • Quality of life [ Time Frame: One year ]
    Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL)


Original Secondary Outcome: Same as current

Information By: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Dates:
Date Received: June 28, 2013
Date Started: June 2008
Date Completion:
Last Updated: July 2, 2013
Last Verified: July 2013