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Ranibizumab

Generic Name
Ranibizumab
Brand Names
Byooviz, Cimerli, Lucentis, Susvimo, Ranivisio, Rimmyrah, Ximluci
Drug Type
Biotech
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)

Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration

Phase 2
Completed
Conditions
Age-Related Macular Degeneration (ARMD)
First Posted Date
2006-02-08
Last Posted Date
2008-06-19
Lead Sponsor
Novartis
Registration Number
NCT00288561
Locations
🇨🇭

Novartis, Basel, Switzerland

Safety and Efficacy of Ranibizumab in Japanese Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Phase 1
Completed
Conditions
Subfoveal Choroidal Neovascularization(CNV) Secondary to Age-related Macular Degeneration (AMD)
Interventions
First Posted Date
2006-01-31
Last Posted Date
2011-02-24
Lead Sponsor
Novartis
Target Recruit Count
88
Registration Number
NCT00284089
Locations
🇯🇵

Novartis, Tokyo, Japan

Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement

Phase 2
Completed
Conditions
Diabetic Macular Edema
Interventions
First Posted Date
2006-01-31
Last Posted Date
2011-02-24
Lead Sponsor
Novartis
Target Recruit Count
151
Registration Number
NCT00284050
Locations
🇨🇭

Novartis, Basel, Switzerland

Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

First Posted Date
2006-01-12
Last Posted Date
2011-03-16
Lead Sponsor
Novartis
Target Recruit Count
353
Registration Number
NCT00275821
Locations
🇨🇭

Novartis, Basel, Switzerland

Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome

Phase 1
Completed
Conditions
Von Hippel-Lindau Syndrome
First Posted Date
2004-08-13
Last Posted Date
2017-07-02
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
5
Registration Number
NCT00089765
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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