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
-

FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration

First Posted Date
2011-12-29
Last Posted Date
2015-03-24
Lead Sponsor
Institut de la Macula y la Retina
Target Recruit Count
17
Registration Number
NCT01500915
Locations
🇪🇸

Institut de la Macula i de la Retina, Barcelona, Spain

Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

First Posted Date
2011-12-15
Last Posted Date
2019-04-17
Lead Sponsor
Allergan
Target Recruit Count
363
Registration Number
NCT01492400

Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

First Posted Date
2011-12-07
Last Posted Date
2011-12-13
Lead Sponsor
University of Sao Paulo
Target Recruit Count
53
Registration Number
NCT01487629
Locations
🇧🇷

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP, Ribeirão Preto, São Paulo, Brazil

Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-11-22
Last Posted Date
2019-05-17
Lead Sponsor
Retina Vitreous Associates of Florida
Target Recruit Count
20
Registration Number
NCT01476449
Locations
🇺🇸

Retina Vitreous Associates of Florida, Saint Petersburg, Florida, United States

Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-11-16
Last Posted Date
2014-03-14
Lead Sponsor
Vitreo-Retinal Associates, PC
Target Recruit Count
20
Registration Number
NCT01472510
Locations
🇺🇸

Vitreo-Retinal Associates, PC, Worcester, Massachusetts, United States

Study EvAluating Genotypes While Using Lucentis 2

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-11-03
Last Posted Date
2019-08-14
Lead Sponsor
University of California, San Diego
Target Recruit Count
66
Registration Number
NCT01464723
Locations
🇺🇸

Shiley Eye Center, University of California, San Diego, San Diego, California, United States

Wet AMD Recurrence Rate in Patients Stable on Three Month Ranibizumab Dosing

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-10-18
Last Posted Date
2012-08-28
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
44
Registration Number
NCT01453920
Locations
🇨🇦

Toronto Western Hospital, Toronto, Ontario, Canada

Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

First Posted Date
2011-10-06
Last Posted Date
2014-08-13
Lead Sponsor
Centre Hospitalier Intercommunal Creteil
Target Recruit Count
45
Registration Number
NCT01448018
Locations
🇫🇷

Intercommunal Hospital, Creteil, France

🇫🇷

Pitie-Salpetriere Hospital, Paris, France

Study to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) in Patients With Wet Age-related Macular Degeneration (wAMD) (AURA)

First Posted Date
2011-10-05
Last Posted Date
2014-01-27
Lead Sponsor
Bayer
Target Recruit Count
2609
Registration Number
NCT01447043

PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)

First Posted Date
2011-10-04
Last Posted Date
2015-02-23
Lead Sponsor
Quark Pharmaceuticals
Target Recruit Count
258
Registration Number
NCT01445899
Locations
🇺🇸

Orange County Reina Medical Group, Santa Ana, California, United States

🇧🇪

Brugmann Ziekenhuis, Laken, Belgium

🇺🇸

Retina Diagnostic Center, Campbell, California, United States

and more 48 locations
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