Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

I

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Terminated

Conditions

Graves Ophthalmopathy

Treatments

Drug: Methimazole
Drug: Pentoxifylline
Drug: Bromocriptine

Study type

Interventional

Funder types

Other

Identifiers

NCT01893450
DIA19508091

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women or men
  • Between 18 and 45 years
  • Autoimmune hyperthyroidism with one year or less of evolution
  • No previous treatment
  • Mild to moderate ophthalmopathy

Exclusion criteria

  • Smoking
  • Severe ophthalmopathy
  • Steroid treatment
  • Asthma
  • Diabetes or other significant disease
  • Creatine >1.5 mg/dl
  • Women with child bearing potential not using a birth control method
  • Opthalmologic diseases
  • Uncontrolled hypertension
  • History of ischemic cardiopathy
  • History of stroke
  • History of gastrointestinal bleeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

31 participants in 3 patient groups

methimazole
Active Comparator group
Description:
methimazole 30 mg daily during one year
Treatment:
Drug: Methimazole
methimazole, bromocriptine
Active Comparator group
Description:
methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year
Treatment:
Drug: Bromocriptine
pentoxifylline
Active Comparator group
Description:
methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year
Treatment:
Drug: Pentoxifylline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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