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

• Sponsor: Yeungnam University College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01614509
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Branch Retinal Vein Occlusion	Procedure: intravitreal bevacizumab monotherapy; Procedure: combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Changes of Central Retinal Thickness [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 Outcome Measures

1. Additional Intravitreal Bevacizumab Injection [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Yeungnam University College of Medicine	Daegu		Korea, Republic of	705-717

Sponsors and Collaborators

• Yeungnam University College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Min Sagong, Assistant Professor, Yeungnam University College of Medicine
• ClinicalTrials.gov Identifier: NCT01614509
• Other Study ID Numbers: PCR-11-144
• First Posted: Jun 8, 2012
• Last Update Posted: Dec 4, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Min Sagong, Assistant Professor, Yeungnam University College of Medicine: branch retinal vein occlusion; bevacizumab; triamcinolone acetonide
• Additional relevant MeSH terms: Retinal Vein Occlusion; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bevacizumab; Triamcinolone diacetate

Study Results

Participant Flow

Recruitment Details	Conditions: Macular edema secondary to Branch Retinal Vein Occlusion The recruitment period: from Jan 2012 to Aug 2012
Pre-assignment Detail	During the follow up period, Not attendants, participants who were received other intraocular surgeries and etc. were excluded.

Arm/Group Title	Monotherapy Group	Combined Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	24	21
COMPLETED	23	18
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	Monotherapy Group	Combined Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	24	21	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 58.3%	14 66.7%	28 62.2%
>=65 years	10 41.7%	7 33.3%	17 37.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.04 (10.498)	60.24 (14.983)	61.20 (12.668)
Sex: Female, Male (Count of Participants)
Female	10 41.7%	10 47.6%	20 44.4%
Male	14 58.3%	11 52.4%	25 55.6%
Region of Enrollment (participants) [Number]
Korea, Republic of	24 100%	21 100%	45 100%

Outcome Measures

1. Secondary Outcome

Title	Additional Intravitreal Bevacizumab Injection
Description	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
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

We evaluated mean times of additional intravitreal injection because of recurrent macular edema within participants who who were finished 6 months follow up periods.

Arm/Group Title	Monotherapy Group	Combined Group
Arm/Group Description	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.	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.
Measure Participants	23	18
Mean (Standard Deviation) [times of injection]	0.96 (0.83)	0.44 (0.70)

2. Primary Outcome

Title	Changes of Central Retinal Thickness
Description	Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection
Time Frame	baseline, 1, 3, 6 months after injection

Outcome Measure Data

Analysis Population Description

Participants who were finished 6 months follow up period.

Arm/Group Title	Monotherapy Group	Combined Group
Arm/Group Description	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.	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.
Measure Participants	23	18
at baseline	510.35 (185.36)	468.22 (159.26)
1 month after injection	291.48 (100.19)	233.33 (79.95)
3 months after injection	265.35 (106.85)	233.22 (57.09)
6 months after injection	246.48 (88.00)	217.83 (42.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Monotherapy Group, Combined Group
	Comments	Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groups
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Central retinal thickness was measured using an optical coherence tomography by every visit intended for all participants.
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Monotherapy Group		Combined Group
Arm/Group Description	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.		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.
All Cause Mortality
	Monotherapy Group		Combined Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Monotherapy Group		Combined Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Monotherapy Group		Combined Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.