Thyroid Associated Orbitopathy
Conditions
Keywords
Thyroid associated orbitopathy, Grave's orbitopathy, Periocular injections, Methotrexate, Triamcinolone
Brief summary
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.
Detailed description
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
Interventions
DRUGMethotrexate
Three periocular injections of methotrexate at week 0, week 3 and week 6.
DRUGTriamcinolone Acetonide
Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Bilateral moderate to severe thyroid associated orbitopathy. 2. Clinical Activity score (CAS) ≥ 3. 3. Duration of thyroid associated orbitopathy \< 2 years
Exclusion criteria
1. Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye. 2. Glaucoma patients or those known to be steroid responders 3. Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess 4. Pregnancy 5. Previous orbital or lid surgeries 6. History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical activity score (CAS) | 2 weeks, 1 month, 3 months and 6 months | Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is \>3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in proptosis | 2 weeks, 1 month, 3 months and 6 months | Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis |
| Change in lid aperture | 2 weeks, 1 month, 3 months and 6 months | Mean change in lid aperture (distance between upper and lower lid margin measured in millimeters by a ruler |
| Percentage of overall responders | 3 months and 6 months | 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 |
Countries
Egypt
Outcome results
None listed