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
-

Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration

First Posted Date
2014-02-12
Last Posted Date
2014-02-12
Lead Sponsor
Università degli Studi di Brescia
Target Recruit Count
60
Registration Number
NCT02060604
Locations
🇮🇹

Spedali Civili di Brescia, Brescia, BS, Italy

Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema

First Posted Date
2014-02-11
Last Posted Date
2017-02-23
Lead Sponsor
GWT-TUD GmbH
Target Recruit Count
25
Registration Number
NCT02059772
Locations
🇩🇪

Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH, Chemnitz, Germany

Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2014-02-05
Last Posted Date
2018-08-22
Lead Sponsor
Federal University of São Paulo
Registration Number
NCT02055911
Locations
🇧🇷

Dept of Ophthalmology - UNIFESP/Hospital São Paulo, São Paulo, SP, Brazil

The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema

First Posted Date
2014-01-31
Last Posted Date
2017-03-16
Lead Sponsor
Aerpio Therapeutics
Target Recruit Count
144
Registration Number
NCT02050828

Safety and Efficacy Study of BCD-021 Compared to Lucentis® in Patients With Neovascular Wet Age-related Macular Degeneration

First Posted Date
2014-01-15
Last Posted Date
2016-03-31
Lead Sponsor
Biocad
Registration Number
NCT02036723
Locations
🇷🇺

Scientific and Research Institute named after Helmholtz, Moscow, Russian Federation

🇷🇺

Regional Clinical Ophthalmic Hospital named TI Yeroshevsky, Samara, Russian Federation

🇧🇷

Hospital dos Olhos do Paraná, Curitiba, Paraná, Brazil

and more 10 locations

A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.

First Posted Date
2014-01-13
Last Posted Date
2019-02-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
200
Registration Number
NCT02034006
Locations
🇮🇹

Novartis Investigative Site, Napoli, Italy

A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema

First Posted Date
2013-11-25
Last Posted Date
2016-10-17
Lead Sponsor
Pfizer
Target Recruit Count
199
Registration Number
NCT01994291
Locations
🇺🇸

Retinal Diagnostic Center, Campbell, California, United States

🇺🇸

Southern California Desert Retina Consultants, Palm Desert, California, United States

🇺🇸

American Institute of Research (Administrative Only), Whittier, California, United States

and more 60 locations

Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-11-19
Last Posted Date
2019-07-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1049
Registration Number
NCT01986907
Locations
🇮🇹

Novartis Investigative Site, Pozzuoli, Italy

Safety and Efficacy of Ranibizumab for Diabetic Macular Edema

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-11-13
Last Posted Date
2020-11-03
Lead Sponsor
Justis Ehlers
Target Recruit Count
27
Registration Number
NCT01982435
Locations
🇺🇸

Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States

🇺🇸

Cole Eye Institute at Hillcrest Hospital, Mayfield Heights, Ohio, United States

Comparison of Treatment Regimens Using Ranibizumab: Intensive (Resolution of Intra- and Sub-retinal Fluid) vs Relaxed (Resolution of Intra-retinal Fluid and/or Sub-retinal Fluid >200µm at the Foveal Centre)

First Posted Date
2013-10-30
Last Posted Date
2019-10-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
349
Registration Number
NCT01972789
Locations
🇦🇺

Novartis Investigative Site, Nedlands, Western Australia, Australia

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