Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Min Sagong, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier:
NCT01614509
First received: June 5, 2012
Last updated: December 3, 2012
Last verified: December 2012
Results First Received: August 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Branch Retinal Vein Occlusion
Interventions: Procedure: intravitreal bevacizumab monotherapy
Procedure: combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Conditions: Macular edema secondary to Branch Retinal Vein Occlusion The recruitment period: from Jan 2012 to Aug 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the follow up period, Not attendants, participants who were received other intraocular surgeries and etc. were excluded.

Reporting Groups
  Description
Monotherapy Group The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
Combined Group The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.

Participant Flow:   Overall Study
    Monotherapy Group     Combined Group  
STARTED     24     21  
COMPLETED     23     18  
NOT COMPLETED     1     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Monotherapy Group The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
Combined Group The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
Total Total of all reporting groups

Baseline Measures
    Monotherapy Group     Combined Group     Total  
Number of Participants  
[units: participants]
  24     21     45  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     14     28  
>=65 years     10     7     17  
Age  
[units: years]
Mean ± Standard Deviation
  62.04  ± 10.498     60.24  ± 14.983     61.20  ± 12.668  
Gender  
[units: participants]
     
Female     10     10     20  
Male     14     11     25  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     24     21     45  



  Outcome Measures
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1.  Primary:   Changes of Central Retinal Thickness   [ Time Frame: baseline, 1, 3, 6 months after injection ]

2.  Secondary:   Additional Intravitreal Bevacizumab Injection   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The limitation of our study include short duration of follow up (6 months) and small populations of study enroll (45 patients)


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Min Sagong
Organization: Yeungnam University College of Medicine
phone: 82-53-620-4191
e-mail: msagong@ynu.ac.kr


No publications provided


Responsible Party: Min Sagong, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT01614509     History of Changes
Other Study ID Numbers: PCR-11-144
Study First Received: June 5, 2012
Results First Received: August 31, 2012
Last Updated: December 3, 2012
Health Authority: Korea: Institutional Review Board