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
-

Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)

First Posted Date
2010-10-20
Last Posted Date
2017-08-14
Lead Sponsor
David M. Brown, M.D.
Target Recruit Count
8
Registration Number
NCT01225146
Locations
🇺🇸

Retina Consultants of Houston, Houston, Texas, United States

Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation

First Posted Date
2010-10-19
Last Posted Date
2020-09-09
Lead Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Target Recruit Count
37
Registration Number
NCT01223612
Locations
🇬🇧

Moorfields Eye Hospital, London, United Kingdom

Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

First Posted Date
2010-10-08
Last Posted Date
2014-02-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
277
Registration Number
NCT01217944
Locations
🇬🇧

Novartis Investigative Site, Wolverhampton, United Kingdom

Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD

Phase 4
Conditions
Interventions
First Posted Date
2010-10-04
Last Posted Date
2016-10-26
Lead Sponsor
University of Cologne
Target Recruit Count
110
Registration Number
NCT01213667
Locations
🇩🇪

University Center of Ophthalmology, Cologne, NRW, Germany

Ranibizumab for Diabetic Traction Retinal Detachment

First Posted Date
2010-09-14
Last Posted Date
2010-09-14
Lead Sponsor
University of Sao Paulo
Target Recruit Count
19
Registration Number
NCT01201161
Locations
🇧🇷

University of São Paulo, Ribeirao Preto, Sao Paulo, Brazil

Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion

First Posted Date
2010-09-10
Last Posted Date
2014-01-13
Lead Sponsor
Peter A Campochiaro, MD
Target Recruit Count
66
Registration Number
NCT01198327
Locations
🇺🇸

Retina Consultants of Houston, Houston, Texas, United States

🇺🇸

Retina-Vitreous Associates Medical Group, Beverly Hills, California, United States

🇺🇸

Retinal Consultants Medical Group, Sacremento, California, United States

and more 3 locations

Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)

First Posted Date
2010-08-26
Last Posted Date
2010-08-26
Lead Sponsor
Seoul Retina Investigator Group
Target Recruit Count
60
Registration Number
NCT01189526
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration

First Posted Date
2010-08-26
Last Posted Date
2016-03-29
Lead Sponsor
Anne Fung MD
Target Recruit Count
40
Registration Number
NCT01189019
Locations
🇺🇸

Pacific Eye Associates, San Francisco, California, United States

🇺🇸

Retina Associates of Kentucky, Lexington, Kentucky, United States

🇺🇸

Tennessee Retina, Nashville, Tennessee, United States

Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-07-29
Last Posted Date
2014-09-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
373
Registration Number
NCT01171976
Locations
🇬🇧

Novartis Investigative Site, Wolverhampton, United Kingdom

Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-07-26
Last Posted Date
2016-05-17
Lead Sponsor
University of New Mexico
Target Recruit Count
10
Registration Number
NCT01169909
Locations
🇺🇸

University of New Mexico Health Science Center, Albuquerque, New Mexico, United States

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