Combined Triple Procedure in Retinal Vein Occlusion (RVO)

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 3

Conditions: Retinal Vein Occlusion

Treatments: Drug: triamcinolone and bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00805064

MK-KTRVO-2008

Details and patient eligibility

About

The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).

Full description

This prospective study of a case series was conducted in 47 patients (n = 47 eyes; f/m: 21/26; mean age: 66.6 years) with ischemic central RVO (CRVO) (n = 15), non-ischemic CRVO (n = 7), or branch RVO (BRVO) (n = 25). A core pars plana vitrectomy with aspiration of 1.5 ml vitreous and infusion of balanced salt solution (BSS; 1 ml), 8 mg (0.4 ml) triamcinolone, and 1.25 mg (0.1 ml) bevacizumab was performed with a single sutureless sclerotomy and a 23 gauge probe tip. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic central RVO (CRVO)
• Non-ischemic CRVO
• Branch RVO (BRVO)

Exclusion criteria

• Visual deterioration due to acute or chronic inflammation
• Post trauma
• Macular edema of other origin
• Intravitreal drug treatment within last 4 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

ischemic CRVO

Active Comparator group

Description:

treatment was applied to this entity

Treatment:

Drug: triamcinolone and bevacizumab

non ischemic CRVO

Active Comparator group

Description:

treatment was applied to this entity

Treatment:

Drug: triamcinolone and bevacizumab

BRVO

Active Comparator group

Description:

treatment was applied to this entity

Treatment:

Drug: triamcinolone and bevacizumab