Ranibizumab

Generic Name
Ranibizumab
Brand Names
Byooviz, Cimerli, Lucentis, Susvimo, Ranivisio, Rimmyrah, Ximluci
Drug Type
Biotech
Chemical Formula
-
CAS Number
347396-82-1
Unique Ingredient Identifier
ZL1R02VT79
Background

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment directed against human vascular endothelial growth factor A (VEGF-A), which is a glycoprotein implicated in the pathophysiology of age-related macular degeneration. Ranibizumab is used to treat various ocular disorders with abnormal growth of blood vessels, such as neovascular (wet) age-related macular degeneration. The development of ranibizumab first began after bevacizumab, another anti-VEGF anticancer drug, was discovered to inhibit neovascularization and used in the off-label treatment of neovascular age-related macular degeneration for intravenous injection. In order to improve drug delivery to the target organ, ranibizumab is available for intravitreal use.

Ranibizumab was initially approved by the FDA in 2006 and by the European Commission (EC) in 2007. It is marketed under the brand names LUCENTIS and SUSVIMO. BYOOVIZ, a biosimilar of LUCENTIS, was approved by Health Canada in March 2022, making it the first and only biosimilar drug of ranibizumab available in Canada. In August 2022, other biosimilars CIMERLI and RAIVISIO were approved by the FDA and EC, respectively.

Indication

Ranibizumab injection for intravitreal use is indicated to treat Neovascular (wet) Age-related Macular Degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

Ranibizumab injection for for intravitreal use via ocular implant is used to treat Neovascular (wet) Age-related Macular Degeneration (AMD) in patients who have responded to at least two intravitreal injections of a VEGF inhibitor.

Associated Conditions
Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema, Myopic Choroidal Neovascularization, Neovascular Age-Related Macular Degeneration (nAMD)
Associated Therapies
-

Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept.

First Posted Date
2013-10-30
Last Posted Date
2019-02-05
Lead Sponsor
Northern California Retina Vitreous Associates
Target Recruit Count
12
Registration Number
NCT01972763
Locations
🇺🇸

Northern California Retina Vitreous Associates, Mountain View, California, United States

Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-10-23
Last Posted Date
2018-12-03
Lead Sponsor
University of Leipzig
Target Recruit Count
27
Registration Number
NCT01968239
Locations
🇩🇪

Department of Ophthalmology, University Leipzig, Leipzig, Germany

Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD

First Posted Date
2013-10-09
Last Posted Date
2019-03-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
712
Registration Number
NCT01958918
Locations
🇨🇭

Novartis Investigative Site, Genève, Switzerland

Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration

Completed
Conditions
Interventions
First Posted Date
2013-09-02
Last Posted Date
2014-10-01
Lead Sponsor
Bayer
Target Recruit Count
137
Registration Number
NCT01933152

An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

First Posted Date
2013-07-26
Last Posted Date
2019-08-12
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
270
Registration Number
NCT01908816
Locations
🇫🇷

Novartis Investigative Site, Vannes, France

Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)

First Posted Date
2013-06-24
Last Posted Date
2017-10-09
Lead Sponsor
Hawaii Pacific Health
Target Recruit Count
24
Registration Number
NCT01884597
Locations
🇺🇸

Retina Consultants of Hawaii, Honolulu, Hawaii, United States

🇺🇸

The Retina Center at Pali Momi, 'Aiea, Hawaii, United States

ESBA1008 Microvolume Study

First Posted Date
2013-05-08
Last Posted Date
2016-03-24
Lead Sponsor
Alcon Research
Target Recruit Count
107
Registration Number
NCT01849692
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