The study objective is to investigate the efficacy and safety of periocular injections of methotrexate in management of patients with active moderate to severe thyroid associated orbitopathy in comparison to periocular injections of triamcinolone acetonide.
Recruited subjects will be randomized such that one orbit receives 3 periocular injections of methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone acetonide at day 0, week 3 and week 6. All study subjects will be followed up for 6 months where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last injection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Three periocular injections of methotrexate at week 0, week 3 and week 6.
Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.
Cairo University
Cairo, Egypt
Change in clinical activity score (CAS)
Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is \>3.
Time frame: 2 weeks, 1 month, 3 months and 6 months
Change in proptosis
Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis
Time frame: 2 weeks, 1 month, 3 months and 6 months
Change in lid aperture
Mean change in lid aperture (distance between upper and lower lid margin measured in millimeters by a ruler
Time frame: 2 weeks, 1 month, 3 months and 6 months
Percentage of overall responders
A participant is considered an overall responder if 2 or more of the following: 1. Improvement of CAS ≥ 2 points. 2. Improvement of proptosis ≥ 2 mm. 3. Improvement of lid aperture ≥ 2 mm. 4. Improvement of soft tissue signs ≥ 1 grade 5. Improvement of EOM ductions
Time frame: 3 months and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.