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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

Tracking Information
First Submitted Date  ICMJE June 5, 2012
First Posted Date  ICMJE June 8, 2012
Results First Submitted Date  ICMJE August 31, 2012
Results First Posted Date  ICMJE December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
Changes of Central Retinal Thickness [ Time Frame: baseline, 1, 3, 6 months after injection ]
Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
Changes of best corrected visual acuity and central retinal thickness [ Time Frame: 6 months ]
Changes of best corrected visual acuity and central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection
Change History Complete list of historical versions of study NCT01614509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
Additional Intravitreal Bevacizumab Injection [ Time Frame: 6 months ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
Re-injection rate [ Time Frame: 6 months ]
Comparison of the re-injection rate of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion
Official Title  ICMJE Not Provided
Brief Summary This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the treatment of macular edema associated with branch retinal vein occlusion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Branch Retinal Vein Occlusion
Intervention  ICMJE
  • Procedure: intravitreal bevacizumab monotherapy
    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.
  • Procedure: combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection
    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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Procedure: intravitreal bevacizumab monotherapy
  • Experimental: 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.
    Intervention: Procedure: combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2012)
45
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2012)
50
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The participant must have macular edema associated branch retinal vein occlusion.
  2. The participant has retinal photographs, optical coherence tomography (OCT) and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice.
  3. The participant must be willing and able to comply with the protocol.

Exclusion Criteria:

  1. The participant has BRVO with other ocular vascular diseases such as central retinal vein occlusion, hypertensive retinopathy, etc.
  2. The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
  3. The participant has a history of treatment for BRVO in the study eye with focal laser photocoagulation, intravitreal triamcinolone acetonide injection or intravitreal Bevacizumab injection
  4. The participant has a history of intraocular surgery (including lens replacement surgery).
  5. The participant has a history of ocular trauma, or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01614509
Other Study ID Numbers  ICMJE PCR-11-144
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Min Sagong, Yeungnam University College of Medicine
Study Sponsor  ICMJE Yeungnam University College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yeungnam University College of Medicine
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP