Endophthalmitis After Intravitreous Anti-VEGF Injections in Patients Receiving vs. Not Receiving Topical Antibiotics
|ClinicalTrials.gov Identifier: NCT02810587|
Recruitment Status : Unknown
Verified June 2016 by Voraporn Chaikitmongkol, Chiang Mai University.
Recruitment status was: Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
|Condition or disease||Intervention/treatment|
|Endophthalmitis||Drug: Topical antibiotics following injection|
Intravitreous anti-VEGF injection has been the most common procedure performed at eye clinics worldwide. It becomes the gold standard treatment for many macular diseases, such as diabetic macular edema and neovascular age-related macular degeneration (AMD). One of the most serious complication after intravitreous injection is post-injection endophthalmitis. There is no proven preventive strategy of post-injection endophthalmitis except the use of povidone iodine. However, a number of physicians around the world prescribe topical antibiotics after the injection, despite the lack of evidence to support the benefit of topical antibiotics to prevent the occurence of endophthalmitis. Recently, many large trials from the US including the Diabetic Retinopathy Clinical Research Network (DRCR.net), the Comparison of AMD Treatment Trials (CATT) study have reported the incidence of post-injection endophthalmitis comparing between eyes receiving versus not receiving post-injection antibiotics, and the results of all studies suggested that topical antibiotics does not help reduce the incidence of post-injection endophthalmitis. In addition, the results suggested that eyes receiving antibiotics had higher rate of endophthalmitis comparing to those not receiving antibiotics. Therefore, a majority of physicians in the United States have stopped prescribing antibiotics drops following the injection. However, a majority of physicians in Asia-Pacific region still prescribe antibiotics drops following the injection (according to the Preferences and Trends (PAT) survey by the American Society of Retina Specialists in 2014).
Due to the limited evidence from Asian literature whether there is difference between incidence of endophthalmitis following intravitreous anti-VEGF injection between eyes receiving antibiotics drops versus not receiving antibiotics drops in the Asian setting, the investigators conducted this study to determine the incidence of endophthalmitis after intravitreous anti-VEGF injection, comparing between eyes receiving post-injection antibiotics versus not receiving. Results from this study would be beneficial to guide an appropriate practice for physicians in the Asian region.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Incidence of Endophthalmitis After Intravitreous Anti-vascular Endothelial Growth Factor Injections Comparison Between Patients Receiving Versus Not Receiving Topical Antibiotics Following the Injections|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2017|
Topical antibiotics group
Those who receive topical antibiotics after intravitreous injection as home medication for 7 days.
Drug: Topical antibiotics following injection
Either receive or not receive topical antibiotics following intravitreous injection
No topical antibiotics group
Those who does NOT receive topical antibiotics after intravitreous injection as home medication.
- Incidence of endophthalmitis [ Time Frame: at least 3 weeks after the injection ]Endophthalmitis is defined as a presence of severe inflammation in the anterior chamber and vitreous cavity, associated with pain, redness, or any degree of decreased vision.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810587
|Contact: Voraporn Chaikitmongkol, MDemail@example.com|
|Contact: Onnisa Nanegrungsunk, MDfirstname.lastname@example.org|