N/A
N=45
Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01614509 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Changes of Central Retinal Thickness — 510.35; 468.22; 291.48; 233.33 micrometer — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intravitreal bevacizumab monotherapy (Procedure); combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Yeungnam University College of Medicine
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes of Central Retinal Thickness |
510.35; 468.22; 291.48; 233.33; 265.35; 233.22 | 0.60 |
| SECONDARY Additional Intravitreal Bevacizumab Injection |
0.96; 0.44 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01614509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.