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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
  Purpose

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.


Condition Intervention
Branch Retinal Vein Occlusion
Procedure: intravitreal bevacizumab monotherapy
Procedure: combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yeungnam University College of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 45
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614509

Locations
Korea, Republic of
Yeungnam University College of Medicine
Daegu, Korea, Republic of, 705-717
Sponsors and Collaborators
Yeungnam University College of Medicine
  More Information

No publications provided

Responsible Party: Min Sagong, Assistant Professor, 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

Keywords provided by Yeungnam University College of Medicine:
branch retinal vein occlusion
bevacizumab
triamcinolone acetonide

Additional relevant MeSH terms:
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis
Bevacizumab
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Enzyme Inhibitors
Glucocorticoids
Growth Inhibitors
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014