Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Change in clinical activity score (CAS)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bilateral moderate to severe thyroid associated orbitopathy.
- •Clinical Activity score (CAS) ≥
- •Duration of thyroid associated orbitopathy < 2 years
Exclusion Criteria
- •Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
- •Glaucoma patients or those known to be steroid responders
- •Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
- •Previous orbital or lid surgeries
- •History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months
Arms & Interventions
Methotrexate
Periocular injections of methotrexate
Intervention: Methotrexate (Drug)
Triamcinolone acetonide
Periocular injections of triamcinolone acetonide
Intervention: Triamcinolone Acetonide (Drug)
Outcomes
Primary Outcomes
Change in clinical activity score (CAS)
Time Frame: 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 Outcomes
- Change in proptosis(2 weeks, 1 month, 3 months and 6 months)
- Change in lid aperture(2 weeks, 1 month, 3 months and 6 months)
- Percentage of overall responders(3 months and 6 months)
Investigators
Islam Youssef Swaify
Principal investigator
Cairo University