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
-

A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-05-01
Last Posted Date
2013-01-18
Lead Sponsor
Genentech, Inc.
Target Recruit Count
1097
Registration Number
NCT00891735

Microperimetry and Optical Coherence Tomography (OCT) With Lucentis for Diabetic Macular Edema (DME)

Phase 2
Conditions
Interventions
First Posted Date
2009-04-22
Last Posted Date
2011-06-27
Lead Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Target Recruit Count
40
Registration Number
NCT00885794
Locations
πŸ‡¦πŸ‡Ή

Rudolf Foundation Clinic, Vienna, Austria

The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration

First Posted Date
2009-03-06
Last Posted Date
2011-08-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
16
Registration Number
NCT00857259
Locations
πŸ‡¬πŸ‡§

Novartis Investigative Site, Southampton, United Kingdom

πŸ‡ΊπŸ‡Έ

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

πŸ‡ΊπŸ‡Έ

Discover Vision Center, Independence, Missouri, United States

and more 4 locations

Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2009-02-19
Last Posted Date
2014-12-11
Lead Sponsor
University of Utah
Registration Number
NCT00846625
Locations
πŸ‡ΊπŸ‡Έ

John Moran Eye Center, Salt Lake City, Utah, United States

Lucentis to Treat Pigment Epithelial Detachment

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-02-11
Last Posted Date
2011-12-08
Lead Sponsor
Lawson Health Research Institute
Target Recruit Count
32
Registration Number
NCT00841581
Locations
πŸ‡¨πŸ‡¦

Ivey Eye Institute, London, Ontario, Canada

Posterior Vitreous Detachment (PVD) Assessment During Dual Retinal Vein Occlusion (RVO) Lucentis Evaluations

First Posted Date
2009-01-28
Last Posted Date
2017-10-30
Lead Sponsor
Barnes Retina Institute
Target Recruit Count
32
Registration Number
NCT00831350
Locations
πŸ‡ΊπŸ‡Έ

Barnes Retina Institute, Saint Louis, Missouri, United States

Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-01-22
Last Posted Date
2014-08-26
Lead Sponsor
University of Miami
Target Recruit Count
6
Registration Number
NCT00826618
Locations
πŸ‡ΊπŸ‡Έ

Bascom Palmer Eye Insitute, Miami, Florida, United States

πŸ‡ΊπŸ‡Έ

Bascom Palmer of the Palm Beaches, Palm Beach Gardens, Florida, United States

Efficacy of Ranibizumab in Combination With Photodynamic Therapy for Wet Age-Related Macular Degeneration

First Posted Date
2008-12-23
Last Posted Date
2008-12-23
Lead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Target Recruit Count
180
Registration Number
NCT00813891
Locations
πŸ‡¨πŸ‡¦

The Royal Victoria Hospital and the Montreal Retinal Institute, Montreal, Quebec, Canada

Treatment Of Radiation Retinopathy Trial

First Posted Date
2008-12-18
Last Posted Date
2009-07-02
Lead Sponsor
Leiden University Medical Center
Target Recruit Count
220
Registration Number
NCT00811200

A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD

First Posted Date
2008-11-19
Last Posted Date
2012-12-19
Lead Sponsor
Subhransu K. Ray, M.D., Ph.D.
Target Recruit Count
40
Registration Number
NCT00793923
Locations
πŸ‡ΊπŸ‡Έ

Bay Area Retina Associates, Walnut Creek, California, United States

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