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241115s2024 xx |||||o 00| ||eng c |
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|a 10.3928/23258160-20240924-01
|2 doi
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|a (NLM)39535413
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|a DE-627
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|c DE-627
|e rakwb
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|a eng
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| 100 |
1 |
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|a Rahhal, Firas M
|e verfasserin
|4 aut
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| 245 |
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|a ONS-5010 (bevacizumab-vikg) Safety and Efficacy in Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
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|c 2024
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|a Text
|b txt
|2 rdacontent
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|a ƒaComputermedien
|b c
|2 rdamedia
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|a ƒa Online-Ressource
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|2 rdacarrier
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|a Date Revised 18.12.2024
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|a published: Print-Electronic
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|a Citation Status Publisher
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|a BACKGROUND AND OBJECTIVE: This was a prospective multicenter, randomized, double-masked, active-controlled study, the aim of which was to demonstrate the efficacy and safety of intravitreal ONS-5010 (bevacizumab-vikg) in eyes with neovascular age-related macular degeneration (nAMD). This was a phase III trial on ONS-5010 (NORSE TWO)
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|a MATERIALS AND METHODS: Treatment-naïve nAMD patients aged 50 years and older with a best-corrected distance visual acuity (BCVA) of 25 to 67 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and evidence of disease activity were included. Subjects randomized to ONS-5010 received monthly intravitreal doses of 1.25 mg of ONS-5010, bevacizumab-vikg (Outlook Therapeutics) for 12 months. Subjects randomized to ranibizumab received 0.50 mg of ranibizumab on days 0, 30, 60, 150, and 240 based on the PIER study dosing regimen
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|a RESULTS: The primary end point was the proportion of subjects who gained ≥ 15 letters from baseline in BCVA at 11 months, and evaluating the safety and tolerability of intravitreal injections of ONS-5010 administered monthly from baseline to 12 months. One hundred thirteen subjects were included in the ONS-5010 group and 115 subjects were included in the ranibizumab group. Respectively, 41.7% and 23.1% of patients gained ≥ 15 letters (3 lines) of visual acuity, with a risk difference of 0.1859 [95% CI = 0.0442, 0.3086]; P = 0.0052. The change in BCVA from baseline to 11 months was found to be 11.2 ± 12.19 and 5.8 ± 14.80 ETDRS letters, respectively. The number of subjects gaining ≥ 5 and ≥ 10 letters and subjects losing < 15 letters was significantly higher in the ONS-5010 group. Similarly, subjects with a Snellen visual acuity equivalent of 20/200 (35 ETDRS letters) or worse at 11 months were significantly fewer in the ONS-5010 group. Only one subject in the ONS-5010 group had a study-related serious ocular adverse event (SAE), namely, elevated intraocular pressure. The most common adverse event in the ONS-5010 group was conjunctival hemorrhage (8.8%), and reduced visual acuity in the ranibizumab group (12.2%)
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|a CONCLUSIONS: In the prescribed treatment plan, ONS-5010 exhibited strong effectiveness in improving or stabilizing visual acuity and was also well tolerated. Bevacizumab and ranibizumab displayed a comparable safety profile. [Ophthalmic Surg Lasers Imaging Retina 2024;55:XX-XX.]
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|a Journal Article
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1 |
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|a Hu, Allen
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Humayun, Mark
|e verfasserin
|4 aut
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| 700 |
1 |
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|a George, Meena S
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Javid, Cameron
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Brown, Jeremiah
|c Jr
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Pitcher, John D
|c 3rd
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Dagnon, Terry
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Kissner, Jennifer
|e verfasserin
|4 aut
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| 773 |
0 |
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|i Enthalten in
|t Ophthalmic surgery, lasers & imaging retina
|d 2013
|g (2024) vom: 01. Nov., Seite 1-12
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|x 2325-8179
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|g year:2024
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|u http://dx.doi.org/10.3928/23258160-20240924-01
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