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Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study.

AbstractPURPOSE:
To evaluate intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion (CRVO).
DESIGN:
Randomized, double-masked, phase 3 study.
METHODS:
A total of 177 patients with macular edema secondary to CRVO were randomized to receive 2 mg intravitreal aflibercept (n = 106) or sham (n = 71) every 4 weeks for 20 weeks. From weeks 24 to 48, patients were monitored every 4 weeks; the former group received intravitreal aflibercept as needed (PRN), and the sham group received sham. From weeks 52 to 76, patients were monitored every 8 weeks, and both groups received intravitreal aflibercept PRN. The primary endpoint (proportion of patients who gained ≥15 letters) was at week 24. This study reports exploratory outcomes at week 76.
RESULTS:
The proportion of patients who gained ≥15 letters in the intravitreal aflibercept and sham groups was 60.2% vs 22.1% at week 24 (patients discontinued before week 24 were considered nonresponders; P < .0001), 60.2% vs 32.4% at week 52 (last observation carried forward, P < .001), and 57.3% vs 29.4% at week 76 (last observation carried forward; P < .001). Mean μm change from baseline central retinal thickness was -448.6 vs -169.3 at week 24 (P < .0001), -423.5 vs -219.3 at week 52 (P < .0001), and -389.4 vs -306.4 at week 76 (P = .1122). Over 76 weeks, the most common ocular serious adverse event in the intravitreal aflibercept group was macular edema (3.8%).
CONCLUSIONS:
The visual and anatomic improvements seen after fixed, monthly dosing at week 24 were largely maintained when treatment intervals were extended. Patients with macular edema following CRVO benefited from early treatment with intravitreal aflibercept.
AuthorsYuichiro Ogura, Johann Roider, Jean-François Korobelnik, Frank G Holz, Christian Simader, Ursula Schmidt-Erfurth, Robert Vitti, Alyson J Berliner, Florian Hiemeyer, Brigitte Stemper, Oliver Zeitz, Rupert Sandbrink, GALILEO Study Group
JournalAmerican journal of ophthalmology (Am J Ophthalmol) Vol. 158 Issue 5 Pg. 1032-8 (Nov 2014) ISSN: 1879-1891 [Electronic] United States
PMID25068637 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2014 Elsevier Inc. All rights reserved.
Chemical References
  • Recombinant Fusion Proteins
  • aflibercept
  • Receptors, Vascular Endothelial Growth Factor
Topics
  • Adult
  • Aged
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections
  • Macular Edema (diagnosis, drug therapy, etiology)
  • Male
  • Middle Aged
  • Prospective Studies
  • Receptors, Vascular Endothelial Growth Factor (administration & dosage)
  • Recombinant Fusion Proteins (administration & dosage)
  • Retinal Vein Occlusion (complications, diagnosis)
  • Time Factors
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Visual Acuity

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