In this retrospective study, electronic medical records (EMR) from current practicing retina specialists were reviewed from 01 July 2010 to 30 July 2020. Based on IRB, patients needed to be ages 18–100, with a diagnosis of exudative age-related macular degeneration (ICD H35.32), received intravitreal anti-VEGF injections of bevacizumab (Avastin; Genentech/Roche), ranibizumab (Lucentis; Genentech/Roche), and aflibercept (Eylea; Regeneron Pharmaceuticals, Inc.), either individualized or in combinations, in a PRN pattern after the first three monthly injections. Patients were excluded if they had macular edema due to other conditions like diabetes, retinal vascular occlusions, high myopia, trauma, or other surgical complications. Patients were also excluded if they were treated by more than one retina specialist and if they were seen by a specialist with less than five cases. All included retina specialists received Accreditation Council for Graduate Medical Education (ACGME) fellowship training in the United States.
Eylea
Manufactured by Regeneron Pharmaceuticals
Sourced in United States
Eylea is an injectable medication used to treat certain eye conditions. It is a prescription medicine that is administered directly into the eye by a healthcare provider. Eylea is designed to help improve or maintain vision in people with these specific eye conditions.
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Lab products found in correlation
Protease inhibitor cocktail, by Merck Group (2 mentions)
30 gauge needle, by Nipro (2 mentions)
Spectralis device, by Heidelberg Engineering (1 mentions)
Avastin, by Genentech (1 mentions)
Aflibercept, by Regeneron Pharmaceuticals (1 mentions)
Lucentis, by Genentech (1 mentions)
Clodrosome, by Encapsula Nanosciences (1 mentions)
Encapsome, by Encapsula Nanosciences (1 mentions)
Hamilton syringe, by Hamilton Company (1 mentions)
7 protocols using eylea
1
Real-World Outcomes of Anti-VEGF Treatments for Exudative AMD
2
Aflibercept Injection Regimen for Retinal Diseases
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In the previous clinical trial [15 (link)], patients were initially administered three injections of aflibercept (2 mg/0.05 mL; Eylea®; Regeneron Pharmaceuticals, Tarrytown, NY, USA) every month, followed by a fixed-dose injection every 8 weeks. A total of eight injections (weeks 0, 4, 8, 16, 24, 32, 40, and 48) were administered during the 56-week study period. At the final follow-up (56 weeks), the following examinations were performed: (1) BCVA measurement; (2) fundus photography; (3) fluorescein angiography; (4) indocyanine green angiography (ICGA); and (5) optical coherence tomography (OCT). However, aflibercept injection was not administered at this final follow-up visit. All the OCT images were obtained using the Spectralis® device (Heidelberg Engineering GmbH, Heidelberg, Germany).
After the 56-week follow-up, the treatment regimen was changed to an as-needed one. Additional injections were administered only if there was evidence of reactivation, such as an increase in intraretinal/subretinal fluid or development of hemorrhage. During the first 12 months, the patients were followed up every 1 to 2 months. Then, the interval between follow-ups was increased to 3 to 4 months for those showing no reactivation of the lesion. Retreatment was performed with either aflibercept or bevacizumab (1.25 mg/0.05 mL; Avastin®, Genentech, San Francisco, CA, USA).
After the 56-week follow-up, the treatment regimen was changed to an as-needed one. Additional injections were administered only if there was evidence of reactivation, such as an increase in intraretinal/subretinal fluid or development of hemorrhage. During the first 12 months, the patients were followed up every 1 to 2 months. Then, the interval between follow-ups was increased to 3 to 4 months for those showing no reactivation of the lesion. Retreatment was performed with either aflibercept or bevacizumab (1.25 mg/0.05 mL; Avastin®, Genentech, San Francisco, CA, USA).
3
Aqueous Humor Sampling for Intravitreal Injections
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Aqueous humor samples of eyes with PNV, PCV, or drusen-associated nAMD were aspirated before intravitreal injection of aflibercept (Eylea; Regeneron Pharmaceuticals, Tarrytown, NY, USA) or ranibizumab (Lucentis; Genentech, South San Francisco, CA, USA) under topical anesthesia using a syringe with a 30-gauge needle (Nipro, Osaka, Japan). The procedure and timing of sample collection were standardized to minimize variance due to the sampling procedure. The aqueous humor of controls was aspirated before cataract surgery in the same manner. The aqueous humor samples were immediately mixed with 2 µL of protease inhibitor cocktail (Sigma-Aldrich, St. Louis, MO, USA) to prevent complement and anaphylatoxin activation. Aliquots of the obtained aqueous humor samples were stored at –80°C until analysis.
4
Treatment for Central Retinal Thickness
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EXAMPLE 12
A subject having a Central Retinal Thickness of greater than or equal to about 600 μm is given 30 mg of the disclosed compounds via subcutaneous injection twice daily for 2 weeks (14 days). On day 14 each eye is given an intravitreal injection of 2 mg aflibercept. Aflibercept is available as Eylea™ from Regeneron Pharmaceuticals, Inc. in single-use glass vials designed to provide 2 mg of aflibercept in a 0.05 mL injection. Administration of the disclosed compounds is continued until the Central Retinal Thickness of each eye is less than about 150 μm.
5
Aqueous Humor Sampling for nAMD Studies
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Aqueous humor samples were aspirated from the eyes with nAMD before intravitreal injection of aflibercept (Eylea, Regeneron Pharmaceuticals) or ranibizumab (Lucentis, Genentech Inc) under topical anesthesia using a syringe with a 30-gauge needle (Nipro). The procedure and timing of the sample collection were standardized to minimize variations in the sampling procedure. The aqueous humor of controls was aspirated before cataract surgery in the same manner. The aqueous humor samples were immediately mixed with 2 μl of protease inhibitor cocktail (Sigma) to prevent complement activation. Aliquots of the obtained aqueous humor samples were stored at −80°C until analysis.
6
Anti-VEGF Regimen for nAMD and PCV
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Our current treatment regimen for nAMD and PCV is 3+pro re nata (PRN): a loading dose of three intravitreal anti-VEGF injections (0.5 mg/0.05 mL, Lucentis, Genentech Inc.; or 0.5 mg/0.05 mL, Conbercept, Chengdu Kanghong Biotech, Inc.; 2 mg/0.05 mL, Eylea, Regeneron Pharmaceuticals Inc.;) followed by additional injections on an ‘as-needed’ basis based on any of the following criteria: (a) Visual deterioration of more than two lines (>0.2 logarithm of the minimum angel of resolution, logMAR); (b) OCT evidence of sub-retinal fluid (SRF), intra-retinal fluid (IRF), or SRH; (c) Central retinal thickness (CRT) increasing more than 100 μm on OCT images; (d) Leakage detected on FA and ICGA examination.22 (link)
The follow-up intervals after anti-VEGF injections were ranging from 4 to 6 weeks. Pars plana vitrectomy (PPV) would be performed for patients with unresolved VH.
The follow-up intervals after anti-VEGF injections were ranging from 4 to 6 weeks. Pars plana vitrectomy (PPV) would be performed for patients with unresolved VH.
7
Intravitreal Injections in Mice
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Anesthetized mice were injected with either BrdU (1 mg/ 0.5 mL), intraocular irrigating solution (Opeguard-MA; Senju Pharmaceutical, Osaka, Japan), anti-VEGF drug (aflibercept; 40 mg/mL; 0.5 mL) (Eylea; Regeneron Pharmaceuticals, Tarrytown, NY, and Bayer, Basel, Switzerland), or human IgG1 (0.5 mL; bingo bio, Hayward, CA), and clodronate encapsulated liposomes (0.5 mL; Clodrosome; Encapsula Nanosciences LLC, Brentwood, TN), or plain liposomes for control (0.5 mL; Encapsome, Encapsula Nanosciences LLC). These were injected intravitreally at $1 mm from the corneal limbus at P14 and P17 using a Hamilton syringe (33-gauge needle; 65460-02; Hamilton Co., Reno, NV). The eyes were enucleated at P21.
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