Abstract | PURPOSE: DESIGN: Randomized, double-masked, phase 3 trial. PARTICIPANTS: METHODS: Patients received IAI 2 mg (IAI 2Q4) (n = 114) or sham injections (n = 74) every 4 weeks up to week 24. During weeks 24 to 52, patients from both arms were evaluated monthly and received IAI as needed, or pro re nata (PRN) (IAI 2Q4 + PRN and sham + IAI PRN). During weeks 52 to 100, patients were evaluated at least quarterly and received IAI PRN. MAIN OUTCOME MEASURES: The primary efficacy end point was the proportion of patients who gained ≥ 15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. This study reports week 100 results. RESULTS: The proportion of patients gaining ≥ 15 letters was 56.1% versus 12.3% (P<0.001) at week 24, 55.3% versus 30.1% (P<0.001) at week 52, and 49.1% versus 23.3% (P<0.001) at week 100 in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + PRN group compared with the sham + IAI PRN group at week 24 (+17.3 vs. -4.0 letters; P<0.001), week 52 (+16.2 vs. +3.8 letters; P<0.001), and week 100 (+13.0 vs. +1.5 letters; P<0.0001). The mean reduction from baseline in central retinal thickness was 457.2 versus 144.8 μm (P<0.001) at week 24, 413.0 versus 381.8 μm at week 52 (P = 0.546), and 390.0 versus 343.3 μm at week 100 (P = 0.366) in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean number (standard deviation) of PRN injections in the IAI 2Q4 + PRN and sham + IAI PRN groups was 2.7 ± 1.7 versus 3.9 ± 2.0 during weeks 24 to 52 and 3.3 ± 2.1 versus 2.9 ± 2.0 during weeks 52 to 100, respectively. The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage (0.9% vs. 6.8% in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively). CONCLUSIONS: The visual and anatomic improvements after fixed dosing through week 24 and PRN dosing with monthly monitoring from weeks 24 to 52 were diminished after continued PRN dosing, with a reduced monitoring frequency from weeks 52 to 100.
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Authors | Jeffrey S Heier, W Lloyd Clark, David S Boyer, David M Brown, Robert Vitti, Alyson J Berliner, Husain Kazmi, Yu Ma, Brigitte Stemper, Oliver Zeitz, Rupert Sandbrink, Julia A Haller |
Journal | Ophthalmology
(Ophthalmology)
Vol. 121
Issue 7
Pg. 1414-1420.e1
(Jul 2014)
ISSN: 1549-4713 [Electronic] United States |
PMID | 24679444
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Recombinant Fusion Proteins
- aflibercept
- Receptors, Vascular Endothelial Growth Factor
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Topics |
- Adult
- Aged
- Double-Blind Method
- Female
- Fluorescein Angiography
- Humans
- Intravitreal Injections
- Macular Edema
(drug therapy, etiology, physiopathology)
- Male
- Middle Aged
- Receptors, Vascular Endothelial Growth Factor
(administration & dosage, adverse effects, therapeutic use)
- Recombinant Fusion Proteins
(administration & dosage, adverse effects, therapeutic use)
- Retina
(pathology)
- Retinal Vein Occlusion
(complications, drug therapy, physiopathology)
- Surveys and Questionnaires
- Treatment Outcome
- Visual Acuity
(physiology)
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