• Users Online: 108
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Contacts Login 
STUDY PROTOCOL
Year : 2017  |  Volume : 2  |  Issue : 4  |  Page : 96-100

Efficacy and safety of combined intravitreal injection of triamcinolone acetonide and ranibizumab in age-related macular degeneration: study protocol for a randomized controlled trial


Jingzhou Central Hospital, Jingzhou Hospital Affiliated to Tongji Medical School of Huazhong University of Science and Technology, Second Clinical Medical College of Yangtze University, Jingzhou, Hubei Province, China

Correspondence Address:
Fen Wei
Jingzhou Central Hospital, Jingzhou Hospital Affiliated to Tongji Medical School of Huazhong University of Science and Technology, Second Clinical Medical College of Yangtze University, Jingzhou, Hubei Province
China
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-3975.222181

Rights and Permissions

Background and objectives: Age-related macular degeneration is a condition that leads to the deterioration of the macula in older adults, 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. Therefore, we aim to determine the efficacy and safety of combined intravitreal injection of triamcinolone acetonide and ranibizumab in the treatment of age-related macular degeneration in a randomized trial. Design: A prospective, single-center, 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 1:1 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. Outcome measures: 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. Discussion: We aim to confirm the safety and efficacy of the combined intravitreal injection of triamcinolone acetonide and ranibizumab in the treatment of age-related macular degeneration. Ethics and dissemination: This study was approved by the Ethics Committee of the Jingzhou Hospital Affiliated to Tongji Medical School 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. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration No. ChiCTR-IOR-17013865).


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed925    
    Printed51    
    Emailed0    
    PDF Downloaded79    
    Comments [Add]    

Recommend this journal