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

June 5, 2012
December 3, 2012
January 2012
August 2012   (final data collection date for primary outcome measure)
Changes of Central Retinal Thickness [ Time Frame: baseline, 1, 3, 6 months after injection ] [ Designated as safety issue: No ]
Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection
Changes of best corrected visual acuity and central retinal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes of best corrected visual acuity and central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection
Complete list of historical versions of study NCT01614509 on ClinicalTrials.gov Archive Site
Additional Intravitreal Bevacizumab Injection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Re-injection rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Comparison of the re-injection rate of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months
Not Provided
Not Provided
 
Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Branch Retinal Vein Occlusion
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
August 2012
August 2012   (final data collection date for primary outcome measure)

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).
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01614509
PCR-11-144
No
Min Sagong, Yeungnam University College of Medicine
Yeungnam University College of Medicine
Not Provided
Not Provided
Yeungnam University College of Medicine
December 2012

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