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

NCT01614509 | Completed Results

• 1 other identifier: PCR-11-144
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Branch Retinal Vein Occlusion

Keywords

branch retinal vein occlusion; bevacizumab; triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• Changes of Central Retinal Thickness

  Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection

  baseline, 1, 3, 6 months after injection

Secondary Outcomes (1)

• Additional Intravitreal Bevacizumab Injection

  6 months

Study Arms (2)

Monotherapy group

EXPERIMENTAL

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

Combined group

EXPERIMENTAL

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

Interventions

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.

Monotherapy group

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.

Combined group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University College of Medicine

Daegu, 705-717, South Korea

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The limitation of our study include short duration of follow up (6 months) and small populations of study enroll (45 patients)

Results Point of Contact

• Title: Dr. Min Sagong
• Organization: Yeungnam University College of Medicine

msagong@ynu.ac.kr

82-53-620-4191

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 8, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 4, 2012
• Results First Posted: December 4, 2012

Record last verified: 2012-12

Locations

KR (1)