Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

NCT05429450 | Completed Phase 2 DMC

• 1 other identifier: MD-139-2020
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Associated Orbitopathy

Keywords

Thyroid associated orbitopathy; Grave's orbitopathy; Periocular injections; Methotrexate; Triamcinolone

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks, 1 month, 3 months and 6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Methotrexate

EXPERIMENTAL

Periocular injections of methotrexate

Drug: Methotrexate

Triamcinolone acetonide

ACTIVE COMPARATOR

Periocular injections of triamcinolone acetonide

Drug: Triamcinolone Acetonide

Interventions

Methotrexate DRUG

Three periocular injections of methotrexate at week 0, week 3 and week 6.

Methotrexate

Triamcinolone Acetonide DRUG

Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.

Triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Bilateral moderate to severe thyroid associated orbitopathy.
• Clinical Activity score (CAS) ≥ 3.
• Duration of thyroid associated orbitopathy \< 2 years

You may not qualify if:

• 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
• Pregnancy
• Previous orbital or lid surgeries
• History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Methotrexate; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Haytham E. Nasr

  Cairo University

  STUDY CHAIR

• Rania A. El Essawy

  Cairo University

  STUDY DIRECTOR

• Kareem B. Elessawy

  Cairo University

  STUDY DIRECTOR

• Islam Y. Swaify

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: June 23, 2022
• Study Start: July 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 15, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)