VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study.

Abstract

AIM:

To evaluate intravitreal VEGF Trap-Eye (VTE) in patients with macular oedema secondary to central retinal vein occlusion (CRVO).

METHODS:

In this double-masked study, 177 patients were randomised (3:2 ratio) to intravitreal injections of VTE 2 mg or sham procedure every 4 weeks for 24 weeks. Best-corrected visual acuity was evaluated using the Early Treatment Diabetic Retinopathy Study chart. Central retinal thickness (CRT) was measured with optical coherence tomography.

RESULTS:

From baseline until week 24, more patients receiving VTE (60.2%) gained ≥ 15 letters compared with those receiving sham injections (22.1%) (p<0.0001). VTE patients gained a mean of 18.0 letters compared with 3.3 letters with sham injections (p<0.0001). Mean CRT decreased by 448.6 and 169.3 µm in the VTE and sham groups (p<0.0001). The most frequent ocular adverse events in the VTE arm were typically associated with the injection procedure or the underlying disease, and included eye pain (11.5%), increased intraocular pressure (9.6%) and conjunctival haemorrhage (8.7%).

CONCLUSIONS:

VTE 2 mg every 4 weeks was efficacious in CRVO with an acceptable safety profile. Vision gains with VTE were significantly higher than with observation/panretinal photocoagulation if needed. Based on these data, VTE may provide a new treatment option for CRVO.

• Authors: Frank G Holz, Johann Roider, Yuichiro Ogura, Jean-François Korobelnik, Christian Simader, Georg Groetzbach, Robert Vitti, Alyson J Berliner, Florian Hiemeyer, Karola Beckmann, Oliver Zeitz, Rupert Sandbrink
• Journal: The British journal of ophthalmology (Br J Ophthalmol) Vol. 97 Issue 3 Pg. 278-84 (Mar 2013) ISSN: 1468-2079 [Electronic] England
• PMID: 23298885 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Fusion Proteins
• aflibercept
• Receptors, Vascular Endothelial Growth Factor

Topics

• Dose-Response Relationship, Drug
• Double-Blind Method
• Follow-Up Studies
• Humans
• Intravitreal Injections
• Macular Edema (drug therapy, etiology, physiopathology)
• Receptors, Vascular Endothelial Growth Factor (administration & dosage)
• Recombinant Fusion Proteins (administration & dosage)
• Retina (pathology)
• Retinal Vein Occlusion (complications, drug therapy, physiopathology)
• Time Factors
• Tomography, Optical Coherence
• Treatment Outcome
• Visual Acuity