Combined intravitreaI injection of triamcinoIone acetonide and ranibizumab for age-reIated macuIar degeneration: study protocoI for a randomized controIIed triaI / 中国组织工程研究

ABSTRACT

BACKGROUND: Age-related macular degeneration is a condition that leads to the deterioration of the macula in the elderly, and is characterized by the presence of drusen and degenerative changes of the retinal pigment epithelium and choroidal capillaries. It is a major cause of blindness worldwide. The commonly used strategies, including antioxidant therapy and dilation of blood vessels, have shown undesired outcomes in clinical practice. Ranibizumab, an anti-vascular endothelial growth factor fusion protein, is an angiogenesis inhibitor that has been used to treat wet (neovascular) age-related macular degeneration; however, patients treated with ranibizumab are prone to develop endophthalmitis, rhegmatogenous retinal detachment, retinal tears, and iatrogenic traumatic cataract. OJECTIVE To determine the efficacy and safety of intravitreal injection of combination of triamcinolone acetonide and ranibizumab in the treatment of age-related macular degeneration in a randomized controlled trial. METHODS: Eighty patients (160 eyes) with age-related macular degeneration admitted at Jingzhou Hospital Affiliated to Tongji Medical School of Huazhong University of Science and Technology, China will be recruited. These patients will be randomly assigned to control or treatment group at a 11 ratio. The patients in the control group will be treated with intravitreal injection of triamcinolone acetonide (0.1 mL, once daily), while those in the treatment group will be treated with combined intravitreal injection of triamcinolone acetonide (0.025 mL, once daily) and ranibizumab (0.05 mL, once a month). All patients will undergo continuous treatment for 3 months, followed by a 6-month follow-up. The primary outcome measure is foveal retinal thickness before and 6 months after treatment. The secondary outcome measures include best corrected visual acuity, intraocular pressure, quality of life scores before and 6 months after treatment, and the incidence of adverse events at 6 months after treatment. This study was approved by the Ethics Committee of the Jingzhou Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, China (approval No. 20170338), and will be performed in accordance with the Declaration of Helsinki. The participants will be informed of the study protocol and procedures and asked to sign an informed consent. Participant recruitment will be initiated in January 2018. Sample and data collection will begin in January 2018 and end in June 2018. The analysis of outcome measures and the completion of trial will be in September 2018. The results of this study will be disseminated through presentations at scientific meetings and/or by publication in peer-reviewed journals. This trial was registered with the Chinese Clinical Trial Registry (registration No. ChiCTR-IOR-17013865). DISCUSSION: We aim to confirm the safety and efficacy of the intravitreal injection of combination of triamcinolone acetonide and ranibizumab in the treatment of age-related macular degeneration.