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Completed

NCT Number: NCT01614509

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

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.

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Key information

Conditions

Branch Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeungnam University College of Medicine

Daegu, 705-717, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The participant must have macular edema associated branch retinal vein occlusion.
  • 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.
  • The participant must be willing and able to comply with the protocol.

Exclusion criteria

  • The participant has BRVO with other ocular vascular diseases such as central retinal vein occlusion, hypertensive retinopathy, etc.
  • 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.
  • 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
  • The participant has a history of intraocular surgery (including lens replacement surgery).
  • The participant has a history of ocular trauma, or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).

Treatment and study plan

intravitreal bevacizumab monotherapy

Procedure

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 therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yeungnam University College of Medicine

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2012
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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