Intravitreal Aflibercept for Treatment-Resistant Neovascular Age-Related Macular Degeneration: 12-Month Safety and Efficacy Outcomes.

Abstract

PURPOSE:

To prospectively assess the safety and efficacy of intravitreal aflibercept for treatment-resistant neovascular age-related macular degeneration (nAMD).

METHODS:

This prospective, non-randomized clinical trial included 49 patients with treatment-resistant nAMD who received 2 mg intravitreal aflibercept as 3 monthly loading doses, followed by injections every 2 months over 12 months. Inclusion criteria included active nAMD on fluorescein angiography at baseline and persistent intra- or subretinal fluid on optical coherence tomography (OCT) for ≥ 6 months prior to baseline with a minimum of 4 injections of bevacizumab and/or ranibizumab. Patients were assessed monthly for best-corrected visual acuity (BCVA), central retinal thickness (CRT) measured with OCT and occurrence of adverse events. Retinal pigment epithelium atrophy (RPEA) was assessed at baseline and at 12 months.

RESULTS:

Mean BCVA improved by 4.7 letters (95% CI: 2.1-7.3, p < 0.001) and CRT decreased by 97.2 µm (95% CI: 54.4-140.1, p < 0.001) at 12 months compared to baseline. Median RPEA area increased by 0.48 mm2 (range = -0.1 to 19.9, p < 0.001). There was 1 arterial thromboembolic event and 2 cases of submacular haemorrhage.

CONCLUSION:

In this cohort of treatment-resistant nAMD patients, intravitreal aflibercept was effective in improving vision and reducing exudation. Early visual and anatomic outcomes may predict longer-term response to treatment, but further assessment is required.

• Authors: Andrew A Chang, Geoffrey K Broadhead, Thomas Hong, Nichole Joachim, Adil Syed, Timothy E Schlub, Levente Toth, Tunde Peto, Meidong Zhu
• Journal: Ophthalmic research (Ophthalmic Res) Vol. 55 Issue 2 Pg. 84-90 ( 2015) ISSN: 1423-0259 [Electronic] Switzerland
• PMID: 26637166 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 S. Karger AG, Basel.

Chemical References

• Angiogenesis Inhibitors
• Recombinant Fusion Proteins
• VEGFA protein, human
• Vascular Endothelial Growth Factor A
• aflibercept
• Receptors, Vascular Endothelial Growth Factor

Topics

• Aged
• Aged, 80 and over
• Angiogenesis Inhibitors (adverse effects, therapeutic use)
• Choroidal Neovascularization (diagnosis, drug therapy)
• Female
• Fluorescein Angiography
• Humans
• Intravitreal Injections
• Male
• Prospective Studies
• Receptors, Vascular Endothelial Growth Factor (adverse effects, therapeutic use)
• Recombinant Fusion Proteins (adverse effects, therapeutic use)
• Tomography, Optical Coherence
• Treatment Outcome
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity (physiology)
• Wet Macular Degeneration (diagnosis, drug therapy)