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Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Bu çalışma, neovasküler yaşa bağlı makula dejenerasyonu (nAMD) olan erişkinlerde surabgen lomparvovec (ABBV-RGX-314) adlı gen terapisini ranibizumab ile karşılaştırmaktadır. Tek uygulamalık gen terapisinin, düzenli göz içi enjeksiyon ihtiyacını azaltıp azaltmadığı ve görme keskinliğini uzun dönemde koruyup korumadığı değerlendirilmektedir. Faz 3 aşamasında yürütülmekte ve katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \[Week -6\]) in the study eye. * Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\^2) * Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator) Exclusion Criteria: * CNV or macular edema in the study eye that is secondary to any causes other than AMD * Study eye with nAMD diagnosed \> 4 years from Screening Visit 1 * Any retinal pigment epithelial detachment \> 400 μm or any pigment epithelial detachment \> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center. * Any subretinal hemorrhage in the study eye \> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center * Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.