BACKGROUND Thyroid-associated ophthalmopathy, a condition commonly associated with Graves’ disease, remains inadequately treated. Current medical therapies, which primarily consist of glucocorticoids, have limited efficacy and present safety concerns. Inhibition of the insulin-like growth factor I receptor (IGF-IR) is a new therapeutic strategy to attenuate the underlying autoimmune pathogenesis of ophthalmopathy. METHODS We conducted a multicenter, double-masked, randomized, placebo-controlled trial to determine the efficacy and safety of teprotumumab, a human monoclonal antibody inhibitor of IGF-IR, in patients with active, moderate-to-severe ophthalmopathy. A total of 88 patients were randomly assigned to receive placebo or active drug administered intravenously once every 3 weeks for a total of eight infusions. The primary end point was the response in the study eye. This response was defined as a reduction of 2 points or more in the Clinical Activity Score (scores range from 0 to 7, with a score of ≥3 indicating active thyroid-associated ophthalmopathy) and a reduction of 2 mm or more in proptosis at week 24. Secondary end points, measured as continuous variables, included proptosis, the Clinical Activity Score, and results on the Graves’ ophthalmopathy–specific quality-of-life questionnaire. Adverse events were assessed. RESULTS In the intention-to-treat population, 29 of 42 patients who received teprotumumab (69%), as compared with 9 of 45 patients who received placebo (20%), had a response at week 24 (P<0.001). Therapeutic effects were rapid; at week 6, a total of 18 of 42 patients in the teprotumumab group (43%) and 2 of 45 patients in the placebo group (4%) had a response (P<0.001). Differences between the groups increased at subsequent time points. The only drug-related adverse event was hyperglycemia in patients with diabetes; this event was controlled by adjusting medication for diabetes. CONCLUSIONS In patients with active ophthalmopathy, teprotumumab was more effective than placebo in reducing proptosis and the Clinical Activity Score. (Funded by River Vision Development and others; ClinicalTrials.gov number, NCT01868997.)
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The clinical and pathological data of 66 patients with orbital cavernous hemangioma are presented. This tumor occurs in females more frequently than in males, and has its peak incidence in early middle age. Visual disability results from a high degree of relative hyperopia or from optic-nerve compression. Postural or temporal variation is proptosis is not characteristic. Multiple cavernous hemangiomas are rare, but may occur simultaneously or separated by long intervals. In this series, incompletely excised lesions did not cause recurrent proptosis. Relative hyperopia may persist, in spite of complete removal of the tumor. Improved preoperative localization with modern techniques appears to be reducing the morbidity associated with surgical excision of the lesion. A local hemodynamic disturbance may initiate proliferation of vascular channels that undergo progressive ectasia. Growth of the lesion may occur intrinsically by the budding-off of capillary channels from cavernous spaces into the interstitium. Clinical and pathological findings fail to demonstrate any relationship between this lesion and capillary hemangioma of childhood.
Twenty-six normal orbits (16 subjects) and seven patients with suspected orbital disease were studied with color Doppler flow imaging CDFI). Arterial structures consistently identified included the ophthalmic artery, central retinal artery, and posterior ciliary branches. The terminal lacrimal branch was seen in the majority of orbits (n = 19). Venous structures consistently seen included the central retinal vein and venae vorticosae; the superior ophthalmic vein was identified in the majority of normal orbits (n = 22). Response of the superior ophthalmic vein to the Valsalva maneuver was assessed in six of the normal subjects (12 orbits). Retrograde flow was typically seen during the maneuver and accentuated antegrade flow after cessation of the maneuver. Pathologic entities correctly diagnosed with CDFI included a dural arteriovenous malformation (AVM) with spontaneous carotid-cavernous fistula, an orbital AVM, and superior ophthalmic vein thrombosis. Vascular lesions were excluded in two patients with orbital masses. Bilaterally enlarged superior ophthalmic veins were identified in a patient with unilateral symptoms suggestive of a varix; CDFI results were confirmed with computed tomography, but orbital venograms were interpreted as normal. These findings suggest that CDFI may be helpful in the evaluation of suspected vascular orbital disease.
IMPORTANCE Current practice to diagnose idiopathic orbital inflammation (IOI) is inconsistent, leading to frequent misdiagnosis of other orbital entities, including cancer. By specifying criteria, diagnosis of orbital inflammation will be improved.OBJECTIVE To define a set of criteria specific for the diagnosis of IOI. DESIGN, SETTING, AND PARTICIPANTSA 3-round modified Delphi process with an expert panel was conducted from June 8, 2015, to January 25, 2016. Fifty-three orbital scientist experts, identified through membership in the Orbital Society, were invited to participate in on online survey and they scored, using 5-point Likert scales, items that are eligible as diagnostic criteria from the literature and from personal experience. The items were clustered around the anatomic subtypes of IOI: idiopathic dacryoadenitis and idiopathic orbital fat inflammation (2 nonmyositic IOIs), and idiopathic orbital myositis (myositic IOI). Items with dissensus were rescored in the second round, and all items with consensus (median, Ն4; interquartile range, Յ1) were ranked by importance in the third round. MAIN OUTCOMES AND MEASURESConsensus on items to be included in the criteria. RESULTSOf the 53 experts invited to participate, a multinational panel of 35 (66%) individuals with a mean (SD) years of experience of 31 (11) years were included. Consensus was achieved on 7 of 14 clinical and radiologic items and 5 of 7 pathologic items related to diagnosis of nonmyositic IOI, and 11 of 14 clinical and radiologic items and 1 of 5 pathologic items for myositic IOI. There was agreement among panelists to focus on surgical tissue biopsy results in the diagnosis of nonmyositic IOI and on a trial with systemic corticosteroids in myositic IOI. Panelists agreed that a maximum number of 30 IgG4-positive plasma cells per high-power field in the orbital tissue is compatible with the diagnosis of IOI.CONCLUSIONS AND RELEVANCE An international panel of experts endorsed consensus diagnostic criteria of IOI. These criteria define a level of exclusion suggested for diagnosis and include tissue biopsy for lesions not confined to the extraocular muscles. This consensus is a step toward developing guidelines for the management of IOI, which needs to be followed by validation studies of the criteria.
Purpose The purpose of this study is to describe the clinical and pathologic features of a form of chronic maxillary atelectasis referred to as the silent sinus syndrome, which is characterized by progressive enophthalmos secondary to maxillary collapse resulting from maxillary sinus hypoventilation. Methods A retrospective medical record analysis was carried out to identify patients with enophthalmos secondary to maxillary collapse. Clinical records, including ophthalmology and otolaryngology evaluations as well as computed tomography scans and operative reports, were carefully examined. A complete literature review for relevant studies was performed to examine possible pathophysiology and similar cases. Results Four patients with enophthalmos and asymptomatic maxillary sinus disease were identified. On computed tomography, all four of the patients had opacified, partially collapsed maxillary sinuses with osteopenia of the sinus walls and orbital floor displacement resulting in enophthalmos. All four underwent successful functional endoscopic sinus surgery and transconjunctival orbital floor repair. Conclusion In some instances, chronic maxillary atelectasis can present with enophthalmos secondary to collapse of the maxillary sinus. For reasons that are unclear, the sinus component of the disease remains asymptomatic and is discovered only after thorough evaluation of the enophthalmos.
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