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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Experimental | Periocular injections of methotrexate |
|
| Triamcinolone acetonide | Active Comparator | Periocular injections of triamcinolone acetonide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Three periocular injections of methotrexate at week 0, week 3 and week 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in proptosis | Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Triamcinolone Acetonide | Drug | Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6. |
|
| 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:
| 3 months and 6 months |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |