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13.
Ophthalmic Surg Lasers Imaging Retina ; 54(3): 153-157, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36944066

RESUMO

BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate the interobserver agreement of the myopic traction maculopathy (MTM) staging system (MSS). PATIENTS AND METHODS: Each observer was asked to look at the MSS Table and then identify, in each optical coherence tomography scan, one among four stages of MTM in the retina, one among three stages in the fovea, and, as secondary findings, the presence or absence of an outer lamellar macular hole and the presence or absence of epiretinal abnormalities. The interobserver agreement value was calculated using the Gwet's AC1 unweighted and AC2 weighted statistics. The outcomes were interpreted as poor (<0.00), slight (0.00 to 0.20), fair (0.21 to 0.40), moderate (0.41 to 0.60), substantial (0.61 to 0.80), or almost perfect (0.81 to 1.00) agreement. RESULTS: The agreement, among 65 participants, was 0.62 (AC1) and 0.77 (AC2) for the retina stage; 0.63 (AC1) and 0.81 (AC2) for the fovea stage; 0.56 (AC1) for the outer lamellar macular hole; and 0.26 (AC1) for epiretinal abnormalities. CONCLUSION: The MSS is highly reproducible and helps ophthalmologists to share information on MTM in a more accurate and reliable way. [Ophthalmic Surg Lasers Imaging Retina 2023;54(3):153-157.].


Assuntos
Degeneração Macular , Miopia Degenerativa , Perfurações Retinianas , Humanos , Perfurações Retinianas/diagnóstico , Perfurações Retinianas/complicações , Tração , Retina , Fóvea Central , Tomografia de Coerência Óptica/métodos , Degeneração Macular/complicações , Estudos Retrospectivos , Miopia Degenerativa/complicações , Miopia Degenerativa/diagnóstico
20.
Ophthalmology ; 128(4): 576-586, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32882310

RESUMO

PURPOSE: The complement pathway may play a key role in the pathogenesis of age-related macular degeneration (AMD). The safety and efficacy of avacincaptad pegol (Zimura, IVERIC bio Inc, New York, NY), a C5 inhibitor, were assessed in participants with geographic atrophy (GA) secondary to AMD (GATHER1 Study). DESIGN: International, prospective, randomized, double-masked, sham-controlled, pivotal phase 2/3 clinical trial. PARTICIPANTS: A total of 286 participants with GA secondary to AMD. MAIN OUTCOME MEASURES: The primary efficacy endpoint was the mean rate of change in GA over 12 months measured by fundus autofluorescence (FAF) at 3 timepoints: baseline, month 6, and month 12. RESULTS: The reduction in the mean rate of GA growth (square root transformation) over 12 months was 27.4% (P = 0.0072) for the avacincaptad pegol 2 mg cohort and 27.8% (P = 0.0051) for the avacincaptad pegol 4 mg cohort compared with their corresponding sham cohorts. The results for both dose groups were statistically significant. Avacincaptad pegol was generally well tolerated after monthly administration over 12 months. There were no avacincaptad pegol-related adverse events (AEs) or inflammation. Further, there were no ocular serious AEs (SAEs) and no cases of endophthalmitis. The most frequent ocular AEs were related to the injection procedure. CONCLUSIONS: Intravitreal administration of avacincaptad pegol 2 mg and 4 mg led to a significant reduction of GA growth in eyes with AMD over a 12-month period. Because C5 inhibition theoretically preserves C3 activity, it may offer additional safety advantages. A second confirmatory pivotal clinical trial is underway to confirm the efficacy and safety of avacincaptad pegol in slowing the GA growth (GATHER2 Study).


Assuntos
Aptâmeros de Nucleotídeos/uso terapêutico , Complemento C5/antagonistas & inibidores , Inativadores do Complemento/uso terapêutico , Atrofia Geográfica/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Angiofluoresceinografia , Seguimentos , Atrofia Geográfica/diagnóstico , Atrofia Geográfica/fisiopatologia , Humanos , Injeções Intravítreas , Degeneração Macular/diagnóstico , Degeneração Macular/tratamento farmacológico , Degeneração Macular/fisiopatologia , Masculino , Estudos Prospectivos , Acuidade Visual/fisiologia
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