drugset / Trial / NCT00532142

The ROVO Study: Radial Optic Neurotomy for CVO

NCT00532142 ↗

Phase 2/3 Completed Rudolf Foundation Clinic
RandomizedParallel-groupSingle-blindTreatment

Summary

The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity \< 0.5 Snellen will be randomised. Patients are treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. Patients will be examined regularly over a period of one year. Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.

Timeline

Start
2005-04
Primary completion
—
Completion
2009-08

Outcome

Met primary endpoint

paper Significantly more patients showed an improvement in VA following RON than in the placebo group (p = 0.009). PMID 22960949 ↗

paper Our study showed that following treatment with RON, patients with CRVO display a significantly better long-term VA than untreated patients and patients treated with a single dose of IVT. PMID 22960949 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Triamcinolone Acetonide Other / unclassified 4 mg Intravitreal