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Graves Ophthalmopathy clinical trials

View clinical trials related to Graves Ophthalmopathy.

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NCT ID: NCT01458600 Completed - Graves´ Disease Clinical Trials

Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)

aGO
Start date: September 2006
Phase: Phase 4
Study type: Interventional

AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months.

NCT ID: NCT01379196 Withdrawn - Clinical trials for Graves Ophthalmopathy

Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy

Start date: May 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to examine the effects of Azithromycin (a macrolide class antibiotic), given three times weekly, for patients with active moderate-severe, non sight-threatening, Graves Orbitopathy. Indices for follow-up will include: - Clinical activity score - Anti-TSH receptor antibody levels - Thickening of extraocular muscles per ultrasound - Quality of life score for Graves Orbitopathy patients

NCT ID: NCT01297699 Completed - Thyroid Eye Disease Clinical Trials

Tocilizumab Treatment in Graves´ Ophthalmopathy (Graves´ Orbitopathy or Thyroid Eye Disease)

GRC
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose is to investigate tocilizumab administration in patients with moderately to severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic alternative. The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment in order to provide a better alternative to surgery for this patients.

NCT ID: NCT01280214 Not yet recruiting - Thyroid Disease Clinical Trials

Local Triamcinolone Injection in Active Thyroid Orbitopathy

Start date: February 2011
Phase: N/A
Study type: Interventional

Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.

NCT ID: NCT01272414 Withdrawn - Clinical trials for Graves Ophthalmopathy

Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction

Start date: January 2011
Phase: Phase 4
Study type: Interventional

Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.

NCT ID: NCT01114503 Terminated - Clinical trials for Graves Ophthalmopathy

A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease

Start date: July 7, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of otelixizumab in patients with Graves' ophthalmopathy (thyroid eye disease). There is currently no alternative therapy available for this condition other than treatment with steroids, or radiotherapy and surgery. The study also includes a comparison of the current steroid treatment, methylprednisolone, with the proposed new otelixizumab treatment.

NCT ID: NCT01056419 Recruiting - Clinical trials for Graves' Ophthalmopathy

The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy

Start date: January 2009
Phase: Phase 4
Study type: Interventional

The relationship between the method of the treatment of hyperthyroidism due to Graves' disease and the course of Graves' ophthalmopathy is debated. The investigators aimed to compare the results of total thyroidectomy done in 6 months following the appearance of the symptoms of ophthalmopathy and the antithyroid drug therapy in patients with moderate to severe Graves' ophthalmopathy. The inclusion criteria: 1)Hyperthyroidism and moderate to severe Graves' ophthalmopathy within 6 months, 2)Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography, 3)Patients taking no treatment except local medications for Graves' ophthalmopathy, 4)Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater than or equal to 9 mm. All patients will be treated with antithyroid drug until TSH levels of the patients are between 0.4-1. During this period all the patients will take pulse methyl prednisolone treatment of a total dose of 4.5 gr. After pulse steroid treatment the patients will be randomised to two groups: one group will be sent to surgery for total thyroidectomy, and their TSH levels will be kept between 0.4-1 with levothyroxine treatment; the other group will be followed under antithyroid drug treatment and their TSH levels will be kept between 0.4-1 also. The smoking habits will be asked. Serum TSH, fT4 levels, Hertelmeter and eye lid opening measurements, clinical activity scores, diplopia will be evaluated monthly; TSH receptor antibody, anti-thyroid peroxidase and anti-thyroglobulin levels will be measured in 3 months intervals for a period of 12 months.

NCT ID: NCT00697528 Completed - Graves' Disease Clinical Trials

Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

Start date: January 2007
Phase: N/A
Study type: Observational

Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging

NCT ID: NCT00665795 Completed - Clinical trials for Dysthyroid Orbitopathy

Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy

Start date: July 2005
Phase: N/A
Study type: Observational

The purpose of this protocol is to study orbital structures in Graves´ Disease using multidetector computed tomography and color doppler imaging. Some changes in orbital structures detected by imaging exams could predict severity of the ocular Graves´disease. Thus the study could be useful in improve medical management of patients with Graves´ Disease.

NCT ID: NCT00595335 Completed - Clinical trials for Thyroid-associated Ophthalmopathy

Trial of Rituximab for Graves' Ophthalmopathy

Start date: April 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study is being done to investigate the effects (good and bad) of Rituximab for the treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven to be difficult to treat. Rituximab is a monoclonal antibody that depletes a line of cells involved in the autoimmune response. The study hypotheses is that rituximab is effective in the treatment of patients with moderate to severe active Graves' ophthalmopathy.