Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Graves Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01893450
• Other study ID #: DIA19508091
• Status: Terminated
• Phase: N/A
• First received: June 28, 2013
• Last updated: July 2, 2013
• Start date: June 2008
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy

Intervention

Drug:
• Methimazole

• Bromocriptine

• Pentoxifylline

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proptosis	Left and right eye proptosis by exophthalmometry	One year	No
Secondary	Clinical activity score	Clinical activity score for Graves' ophthalmopathy	One year	No
Secondary	Quality of life	Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL)	One year	No