Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

• Status: Active, not recruiting
• Trial end date: 2022-07-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Methotrexate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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