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RESEARCH ARTICLE
Year : 2018  |  Volume : 3  |  Issue : 2  |  Page : 77-82

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


Department of Ophthalmology, Affiliated Hospital of Qinghai University, Xining, Qinghai Province, China

Correspondence Address:
Ping Yu
Department of Ophthalmology, Affiliated Hospital of Qinghai University, Xining, Qinghai Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-3975.235151

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Background and objectives: The lack of visual field in the visual center of older adults with age-related macular degeneration (AMD) has a serious impact on daily activities. AMD is subdivided into atrophic and exudative AMD according to pathology. Patients with advanced stage exudative AMD develop aged-related degeneration in the macular area. Ranibizumab combined with photodynamic therapy is mainly used for the treatment of early exudative AMD; however, treatment outcomes in advanced stage exudative AMD are not well documented. Therefore, we attempt to analyze vision recovery, retinal thickness, and leakage of choroidal neovascular lesions in patients with advanced stage exudative AMD after treatment with ranibizumab plus photodynamic therapy. We also further explore the therapeutic efficacy of the combined therapy. Design: A prospective self-controlled trial. Methods: The trial will be undertaken in the Department of Ophthalmology, Affiliated Hospital of Qinghai University, China. The study population will comprise 113 patients with advanced exudative AMD who are eligible for inclusion. Photodynamic therapy combined with intravitreal injection of ranibizumab will be given as the interventional therapy. Outcome measures and preliminary results: The primary outcome measure of the trial is 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. Adverse events are also recorded during follow-up. Pre-test 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 compared with before treatment. Leakage of choroidal neovascular lesions in most affected eyes stopped or the lesions were contracted. Discussion: 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. This will provide a basis for the rational use of this combined therapy in the treatment of advanced exudative AMD. Ethics and dissemination: The study was designed in December 2017, and approved by the Ethics Committee of the Affiliated Hospital of Qinghai University (approval No. QHY001Y) in January 2018. The trial was registered with the Chinese Clinical Trial Registry in March 28, 2018. Participant recruitment was initialized in March 2018, and data analysis will be completed in December 2020. The results of this study will be disseminated by publications in peer-reviewed journals. Trial registration: This trial was registered in the Chinese Clinical Trial Registry with registration No. ChiCTR1800015410 (protocol version 1.0).


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