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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)

Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

Phase 2
Completed
Conditions
Choroidal Neovascularization
Macular Degeneration
Interventions
First Posted Date
2007-06-27
Last Posted Date
2011-06-02
Lead Sponsor
QLT Inc.
Target Recruit Count
162
Registration Number
NCT00492284
Locations
🇺🇸

Retina Centers, PC, Tucson, Arizona, United States

A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRUISE)

Phase 3
Completed
Conditions
Macular Edema
Retinal Vein Occlusion
Interventions
First Posted Date
2007-06-13
Last Posted Date
2017-07-28
Lead Sponsor
Genentech, Inc.
Target Recruit Count
392
Registration Number
NCT00485836

A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)

Phase 3
Completed
Conditions
Macular Edema
Retinal Vein Occlusion
Interventions
First Posted Date
2007-06-13
Last Posted Date
2017-05-10
Lead Sponsor
Genentech, Inc.
Target Recruit Count
397
Registration Number
NCT00486018

Study Evaluating Genotypes Using Lucentis

Terminated
Conditions
Age-Related Maculopathy
Interventions
First Posted Date
2007-05-17
Last Posted Date
2015-02-11
Lead Sponsor
University of Utah
Target Recruit Count
65
Registration Number
NCT00474695
Locations
🇺🇸

California Retina Consultants, Santa Barbara, California, United States

🇺🇸

Porter Adventist Hospital, Denver, Colorado, United States

🇺🇸

University of Utah, Moran Eye Center, Salt Lake City, Utah, United States

A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RIDE)

Phase 3
Completed
Conditions
Diabetes Mellitus
Macular Edema
Interventions
Drug: Sham injection
First Posted Date
2007-05-15
Last Posted Date
2017-04-17
Lead Sponsor
Genentech, Inc.
Target Recruit Count
382
Registration Number
NCT00473382

Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

Phase 4
Completed
Conditions
Choroidal Neovascularization
Age-Related Maculopathy
Interventions
First Posted Date
2007-05-15
Last Posted Date
2020-11-06
Lead Sponsor
Oklahoma State University Center for Health Sciences
Target Recruit Count
31
Registration Number
NCT00473642
Locations
🇺🇸

Eagle Mountain Vision, Tulsa, Oklahoma, United States

A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RISE)

Phase 3
Completed
Conditions
Macular Edema
Diabetes Mellitus
Interventions
Drug: Sham injection
First Posted Date
2007-05-15
Last Posted Date
2017-04-17
Lead Sponsor
Genentech, Inc.
Target Recruit Count
377
Registration Number
NCT00473330

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

Phase 3
Completed
Conditions
Choroidal Neovascularization
Age-Related Macular Degeneration
Interventions
First Posted Date
2007-05-08
Last Posted Date
2016-11-18
Lead Sponsor
Novartis
Target Recruit Count
95
Registration Number
NCT00470678
Locations
🇨🇳

Novartis Investigative Site, LinKou, Taiwan

🇨🇳

Novartis Investigative site, Taipei, Taiwan

Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy

Phase 1
Completed
Conditions
Coats' Disease
Idiopathic Retinal Telangiectasia
Retinal Angiomatous Proliferation
Polypoidal Choroidal Vasculopathy
Pseudoxanthoma Elasticum
Pathological Myopia
Multi-focal Choroiditis
Rubeosis Iridis
Von Hippel Lindau Disease
BEST VITELLIFORM MACULAR DYSTROPHY, MULTIFOCAL (Disorder)
Interventions
First Posted Date
2007-05-08
Last Posted Date
2012-10-25
Lead Sponsor
Manhattan Eye, Ear & Throat Hospital
Target Recruit Count
18
Registration Number
NCT00470977
Locations
🇺🇸

Lenox Hill Hospital/Manhattan Eye, Ear & Throat Institute, New York, New York, United States

🇺🇸

Lenox Hill Hospital/Manhattan Eye Ear and Throat Institute, New York, New York, United States

A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD

Phase 3
Completed
Conditions
Macular Degeneration
First Posted Date
2007-05-04
Last Posted Date
2011-07-22
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
150
Registration Number
NCT00469352
Locations
🇺🇸

Casey Eye Institute, Oregon Health and Science University, Portland, Oregon, United States

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