Official Title: “Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion”

Branch retinal vein occlusion (BRVO) is a common retinal vascular disease occurring in a significant number of individuals older than 50 years.The most common cause of visual disturbance in BRVO patients is macular edema, which has been reported in 60% of patients.

Macular grid laser photocoagulation has been shown to be effective in the treatment of macular edema arising from BRVO. Some eyes are resistant to conventional grid laser treatment, and the conventional treatment is not useful in patients with intraretinal hemorrhages that may interfere with laser photocoagulation. Moreover, several studies have shown that conventional grid laser treatment for macular edema may be associated with complications.

Intravitreal triamcinolone acetonide (IVTA) injection has recently been reported to be effective in the treatment of macular edema of various etiologies.On the other hand, arteriovenous sheathotomy is a surgical method suggested for treatment of macular edema in BRVO patients, and has been reported to be efficacious in patients refractory to conventional focal or grid laser macular photocoagulation.Both treatment modalities have been reported to be associated with reductions in central macular thicknesses and improved visual acuities.

The purpose of the study is to compare the efficacies of arteriovenous (AV) sheathotomy and intravitreal triamcinolone (IVTA) injection in the treatment of macular edema associated with branch retinal vein occlusion (BRVO).

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

• Procedure: Arteriovenous Crossing Sheathotomy
  • In each sheathotomy patient, a standard pars plana vitrectomy is performed, followed by surgical separation of the posterior cortical vitreous from the optic nerve and posterior retina. After the relevant arteriovenous crossing site is identified based on preoperative FA, a bent microvitreoretinal blade is used to open the internal limiting membrane and the nerve fiber layer over the artery, with the incision commencing 100-200 micrometer proximal to the AV crossing. The incision is continued parallel to and under the retinal arteriole, with a gentle lifting motion, until the common AV crossing sheath is encountered and incised in a side-to-side manner. The completion of AV dissection is confirmed by an elevation of the overlying artery.
• Procedure: Intravitreal Triamcinolone Acetonide Injection
  • The IVTA group receive intravitreal injection of 4 mg/0.1 mL triamcinolone acetonide (40 mg/mL; Tamceton®; Hanall Pharmaceutical, Seoul, Korea). The injections are performed using 0.5% proparacaine drops (Alcaine®; Alcon Laboratories, Fort Worth, TX) for topical anesthesia under sterile conditions. The drug is injected through the inferotemporal pars plana using a 30-gauge needle. The correct intravitreal localization of the suspension, and perfusion of the optic nerve head, are then confirmed by indirect ophthalmoscopy.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • The group 1 patients receive AV sheathotomy for macular edema secondary to branch retinal vein occlusion.
• Active Comparator: 2
  • The group 2 patients receive IVTA.

Primary Measures

• best-corrected ETDRS visual acuity score
  • Time Frame: baseline, at 1,3,6 months after either treatment
    Safety Issue?: No

Secondary Measures

• complication rate
  • Time Frame: at 1,3,6 months after either treatment
    Safety Issue?: Yes

Inclusion Criteria:

• recent onset (within the 6 months prior to enrollment) of macular edema resulting from

BRVO

• best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) scores ≤ 40 letters (Snellen equivalent ≤ 20/40
• intraretinal hemorrhages involving the foveal centers
• generalized breakdown of the inner blood-retina barrier, as documented by diffuse fluorescein leakage on angiography, or diffuse thickening of the retina on optical coherence tomography (OCT), with involvement of the foveal center and most of the macular area, and with foveal thicknesses ≥ 250 micrometer

Exclusion Criteria:

• prior history of intraocular surgery including cataract extraction
• prior history of laser treatments including panretinal photocoagulation and focal/grid macular photocoagulation
• prior history of elevated intraocular pressure secondary to steroid treatment
• prior history of glaucoma or ocular hypertension
• presence of comorbid ocular conditions that might affect visual acuity (VA).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yonsei University

Overall Clinical Trial Officials and Contacts

Hyoung Jun Koh, MD, PhD Principal Investigator Yonsei University Heath System  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612261

Study ID Number: koh003

ClinicalTrials.gov Identifier: NCT00612261

Health Authority: Korea: Food and Drug Administration