Ranibizumab combined with photodynamic therapy for the treatment of advanced-stage exudative age-related macular degeneration: study protocol for a self-controlled trial and preliminary results / 中国组织工程研究

ABSTRACT

BACKGROUND: The lack of visual field in the visual center of older adults with aged-related macular degeneration (AMD) will have a serious impact on the activities of daily living. There are atrophic and exudative AMD according to the pathological manifestations. Patients with advanced stage of exudative AMD will develop aged-related degeneration in the macular area. Ranibizumab combined with photodynamic therapy is mainly used for current treatment of exudative AMD, but more attention is paid to patients with early exudative AMD. OBJECTIVE: To analyze vision recovery, retinal thickness, and leakage of choroidal neovascular lesions in patients with advanced stage of exudative AMD after treatment with ranibizumab plus photodynamic therapy, and further explore the therapeutic efficacy of the combined therapy. METHODS: The prospective self-controlled trial will be completed in the Department of Ophthalmology, Affiliated Hospital of Qinghai University in China. The study population will comprise 113 patients with advanced exudative AMD who are eligible for inclusion and exclusion criteria. Photodynamic therapy combined with intravitreal injection of ranibizumab will be given as the interventional therapy. RESULTS AND CONCLUSION: The primary outcome measure of the trial is to investigate the visual improvement in patients 12 months after treatment. Secondary outcome measures include logarithmic visual acuity chart scores, retinal thickness, and leakage of choroidal neovascular lesions assessed monthly at 1-12 months after treatment, and adverse events during follow-up. Preliminary results showed that at 12 months after treatment, visual acuity in 43 affected eyes was increased by ≥ 2 lines, and the average retinal thickness decreased by 111.21 μm as compared with before treatment. Leakage of choroidal neovascular lesions in most affected eyes stopped or the lesions were contracted. Findings from the trial are expected to provide reliable data on the efficacy of ranibizumab combined with photodynamic therapy in the treatment of advanced exudative AMD, thereby providing a basis for the rational use of this combined therapy in the treatment of advanced exudative AMD. This trial was registered with the Chinese Clinical Trial Registry (registration number ChiCTR1800015410). Protocol version (1.0).