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

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ClinicalTrials.gov Identifier: NCT01614509
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Min Sagong, Yeungnam University College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 45
Recruitment Details Conditions: Macular edema secondary to Branch Retinal Vein Occlusion The recruitment period: from Jan 2012 to Aug 2012
Pre-assignment Details During the follow up period, Not attendants, participants who were received other intraocular surgeries and etc. were excluded.
Arm/Group Title Monotherapy Group Combined Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 24 21
Completed 23 18
Not Completed 1 3
Arm/Group Title Monotherapy Group Combined Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 24 21 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  58.3%
14
  66.7%
28
  62.2%
>=65 years
10
  41.7%
7
  33.3%
17
  37.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 21 participants 45 participants
62.04  (10.498) 60.24  (14.983) 61.20  (12.668)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 45 participants
Female
10
  41.7%
10
  47.6%
20
  44.4%
Male
14
  58.3%
11
  52.4%
25
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 24 participants 21 participants 45 participants
24 21 45
1.Primary Outcome
Title Changes of Central Retinal Thickness
Hide Description Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection
Time Frame baseline, 1, 3, 6 months after injection
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were finished 6 months follow up period.
Arm/Group Title Monotherapy Group Combined Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 23 18
Mean (Standard Deviation)
Unit of Measure: micrometer
at baseline 510.35  (185.36) 468.22  (159.26)
1 month after injection 291.48  (100.19) 233.33  (79.95)
3 months after injection 265.35  (106.85) 233.22  (57.09)
6 months after injection 246.48  (88.00) 217.83  (42.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monotherapy Group, Combined Group
Comments Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groups
Type of Statistical Test Non-Inferiority or Equivalence
Comments Central retinal thickness was measured using an optical coherence tomography by every visit intended for all participants.
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Additional Intravitreal Bevacizumab Injection
Hide Description Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
We evaluated mean times of additional intravitreal injection because of recurrent macular edema within participants who who were finished 6 months follow up periods.
Arm/Group Title Monotherapy Group Combined Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 23 18
Mean (Standard Deviation)
Unit of Measure: times of injection
0.96  (0.83) 0.44  (0.70)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Monotherapy Group Combined Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Monotherapy Group Combined Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Monotherapy Group Combined Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Monotherapy Group Combined Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/21 (0.00%) 
The limitation of our study include short duration of follow up (6 months) and small populations of study enroll (45 patients)
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
Responsible Party: Min Sagong, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT01614509     History of Changes
Other Study ID Numbers: PCR-11-144
First Submitted: June 5, 2012
First Posted: June 8, 2012
Results First Submitted: August 31, 2012
Results First Posted: December 4, 2012
Last Update Posted: December 4, 2012