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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
-

Ranibizumab and Reduced Fluence PDT for AMD

Phase 2
Completed
Conditions
Macular Degeneration
Interventions
First Posted Date
2007-09-11
Last Posted Date
2013-06-07
Lead Sponsor
Texas Retina Associates
Target Recruit Count
60
Registration Number
NCT00527475
Locations
🇺🇸

California Retina Consultants & Research Foundation, Santa Barbara, California, United States

🇺🇸

Associated Retinal Consultants, Ann Arbor, Michigan, United States

🇺🇸

Texas Retina Associates, Arlington, Texas, United States

Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Phase 4
Completed
Conditions
Secondary to Age-related Macular Degeneration (AMD)
Subfoveal Choroidal Neovascularization (CNV)
Interventions
First Posted Date
2007-07-20
Last Posted Date
2016-03-04
Lead Sponsor
Novartis
Target Recruit Count
234
Registration Number
NCT00504959
Locations
🇹🇷

Novartis Investigative SIte, Ankara, Turkey

🇦🇺

Novartis Investigational Site, Melbourne, Australia

🇬🇧

Novartis Investigative Site, Wolverhampton, United Kingdom

Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD

Phase 3
Terminated
Conditions
Macular Degeneration
Interventions
First Posted Date
2007-07-11
Last Posted Date
2014-10-06
Lead Sponsor
OPKO Health, Inc.
Target Recruit Count
338
Registration Number
NCT00499590
Locations
🇺🇸

Retina Institute of California (site 207), Pasadena, California, United States

🇺🇸

Miramar Eye Specialists Medical Group (site 245), Ventura, California, United States

🇺🇸

Florida Eye Microsurgical Institute, Inc. (site 217), Boynton Beach, Florida, United States

and more 57 locations

Lucentis for Inflammatory Macular Edema Trial

Phase 1
Completed
Conditions
Uveitis
Cytoid Macular Edema
Interventions
First Posted Date
2007-07-10
Last Posted Date
2017-11-30
Lead Sponsor
University of California, San Francisco
Target Recruit Count
7
Registration Number
NCT00498355
Locations
🇺🇸

Proctor Foundation, UCSF, San Francisco, California, United States

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

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 (RIDE)

Phase 3
Completed
Conditions
Diabetes Mellitus
Macular Edema
Interventions
Drug: Ranibizumab
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

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
Drug: Ranibizumab
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

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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