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
-

Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2011-07-26
Last Posted Date
2019-08-28
Lead Sponsor
University of California, San Diego
Target Recruit Count
20
Registration Number
NCT01402544
Locations
🇺🇸

California Retina Consultants, Santa Barbara, California, United States

🇺🇸

Shiley Eye Center, UCSD, La Jolla, California, United States

🇺🇸

Medical Center Ophthalmology Associates, San Antonio, Texas, United States

Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

First Posted Date
2011-07-19
Last Posted Date
2019-04-16
Lead Sponsor
Allergan
Target Recruit Count
271
Registration Number
NCT01397409

Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)

First Posted Date
2011-07-18
Last Posted Date
2014-08-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
244
Registration Number
NCT01396057
Locations
🇬🇧

Novartis Investigative Site, York, United Kingdom

Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)

First Posted Date
2011-07-18
Last Posted Date
2016-09-27
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
243
Registration Number
NCT01396083
Locations
🇬🇧

Novartis Investigative Site, York, United Kingdom

Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-06-21
Last Posted Date
2016-11-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
47
Registration Number
NCT01377597
Locations
🇯🇵

Novartis Investigative Site, Osaka, Japan

Evaluation of Wet Age-Related Macular Degeneration (AMD) Genetic Profile Interactions With Ranibizumab Treatment Outcomes

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2011-06-01
Last Posted Date
2016-03-17
Lead Sponsor
McMaster University
Target Recruit Count
70
Registration Number
NCT01363570
Locations
🇨🇦

St. Joseph's Healthcare Hamilton Regional Eye Centre, Hamilton, Ontario, Canada

🇨🇦

Toronto Western Hospital Eye Clinic, Toronto, Ontario, Canada

Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

First Posted Date
2011-03-29
Last Posted Date
2013-05-27
Lead Sponsor
Jang Won Heo
Target Recruit Count
34
Registration Number
NCT01325181
Locations
🇰🇷

• Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Gyeonggi-do, Korea, Republic of

Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

First Posted Date
2011-03-21
Last Posted Date
2016-05-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
30490
Registration Number
NCT01318941
Locations
🇻🇪

Novartis Investigative Site, Torre Venezuela, Piso 1, Venezuela

A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-03-15
Last Posted Date
2017-02-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
394
Registration Number
NCT01315275
Locations
🇫🇷

Novartis Investigative Site, Vannes, France

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