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
-

Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

First Posted Date
2012-12-11
Last Posted Date
2012-12-11
Lead Sponsor
University of Sao Paulo
Target Recruit Count
30
Registration Number
NCT01746563
Locations
🇧🇷

Universidade of Sao Paulo, Sao Paulo, Brazil

Genetic Polymorphisms in Ranibizumab Treatment in Wet Age-Related Macular Degeneration (AMD)

Not Applicable
Conditions
First Posted Date
2012-08-31
Last Posted Date
2012-08-31
Lead Sponsor
Russian Academy of Medical Sciences
Target Recruit Count
300
Registration Number
NCT01676506
Locations
🇷🇺

State Research Institute of Eye Disease of Russian Academy of Medical Sciences, Moscow, Russian Federation

Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-08-10
Last Posted Date
2019-05-31
Lead Sponsor
Queen's University
Target Recruit Count
10
Registration Number
NCT01661946
Locations
🇨🇦

Hotel Dieu Hospital, Kingston, Ontario, Canada

Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (BRVO)

First Posted Date
2012-07-10
Last Posted Date
2015-07-01
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
296
Registration Number
NCT01635803
Locations
🇳🇱

Academic Medical Center, Dept. Ophthalmology, Amsterdam, Netherlands

Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (BRDME)

First Posted Date
2012-07-10
Last Posted Date
2015-07-01
Lead Sponsor
Prof. dr. R.O. Schlingemann
Target Recruit Count
246
Registration Number
NCT01635790
Locations
🇳🇱

Academic Medical Center, Dept. Ophthalmology,, Amsterdam, Netherlands

Study to Investigate the Safety and Efficacy of Ranibizumab in Patients With Choroidal Neovascularisation Due to Causes Other Than Age Related Macular Degeneration

First Posted Date
2012-06-26
Last Posted Date
2012-06-28
Lead Sponsor
University of Melbourne
Target Recruit Count
49
Registration Number
NCT01628354
Locations
🇦🇺

Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia

Ranibizumab and Bevacizumab for Diabetic Macular Edema

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-06-04
Last Posted Date
2022-12-09
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
56
Registration Number
NCT01610557
Locations
🇬🇧

Bristol Eye Hospital, Bristol, United Kingdom

🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion

First Posted Date
2012-05-16
Last Posted Date
2016-11-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
455
Registration Number
NCT01599650
Locations
🇬🇧

Novartis Investigative Site, Southampton, United Kingdom

Lucentis KAV Study

First Posted Date
2012-04-04
Last Posted Date
2012-04-04
Lead Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Target Recruit Count
51
Registration Number
NCT01570608
Locations
🇦🇹

Department of OPhthalmology Medical center east, Vienna, Austria

🇦🇹

Department of Ophthalmology Rudolf foundation Clinic, Vienna, Austria

🇦🇹

Department of Ophthalmology, Hospital Hietzing, Vienna, Austria

The LIMO Study, Lucentis for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema

First Posted Date
2012-03-27
Last Posted Date
2019-03-27
Lead Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Target Recruit Count
10
Registration Number
NCT01564108
Locations
🇬🇧

Moorfields Eye Hospital NHSFT Research and Treatment Centre, London, United Kingdom

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