MedPath

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
-

Injected Ranibizumab to Treat Macular Telangiectasia With New Blood Vessel Formation

Phase 1
Completed
Conditions
Telangiectasia
First Posted Date
2007-04-05
Last Posted Date
2017-07-02
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
5
Registration Number
NCT00457067
Locations
๐Ÿ‡บ๐Ÿ‡ธ

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

Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation

Phase 1
Completed
Conditions
Telangiectasia
First Posted Date
2007-04-05
Last Posted Date
2017-07-02
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
5
Registration Number
NCT00457145
Locations
๐Ÿ‡บ๐Ÿ‡ธ

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

Effect of Ranibizumab on Malignant Conjunctival Neoplasia

Phase 1
Completed
Conditions
Conjunctival Neoplasms
Interventions
First Posted Date
2007-04-05
Last Posted Date
2017-07-21
Lead Sponsor
The New York Eye Cancer Center
Target Recruit Count
5
Registration Number
NCT00456495
Locations
๐Ÿ‡บ๐Ÿ‡ธ

The New York Eye Cancer Center, New York, New York, United States

A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration

Phase 3
Conditions
Macular Degeneration
Interventions
Device: Epi-Rad90โ„ข Ophthalmic System
Drug: ranibizumab
First Posted Date
2007-03-30
Last Posted Date
2011-07-27
Lead Sponsor
NeoVista
Target Recruit Count
494
Registration Number
NCT00454389
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Southeast Retina Center, Augusta, Georgia, United States

๐Ÿ‡บ๐Ÿ‡ธ

Paducah Retinal Center, Paducah, Kentucky, United States

๐Ÿ‡บ๐Ÿ‡ธ

Retina Research Unit of Wills Eye Hospital, Philadelphia, Pennsylvania, United States

and more 29 locations

Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy

Phase 3
Completed
Conditions
Diabetic Macular Edema
Proliferative Diabetic Retinopathy
Interventions
Behavioral: Sham injection
Drug: Ranibizumab
Drug: Triamcinolone Acetonide
Procedure: Focal/grid laser
First Posted Date
2007-03-08
Last Posted Date
2016-08-26
Lead Sponsor
Jaeb Center for Health Research
Target Recruit Count
333
Registration Number
NCT00445003
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of Illinois at Chicago Medical Center, Chicago, Illinois, United States

๐Ÿ‡บ๐Ÿ‡ธ

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

๐Ÿ‡บ๐Ÿ‡ธ

Southeast Retina Center, P.C., Augusta, Georgia, United States

and more 51 locations

Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema

Phase 1
Completed
Conditions
Clinically Significant Diabetic Macular Edema
Interventions
First Posted Date
2007-02-27
Last Posted Date
2013-08-02
Lead Sponsor
Philip J. ferrone, M.D.
Target Recruit Count
50
Registration Number
NCT00440609
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Long Island Vitreoretinal Consultants, Hauppauge, New York, United States

Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

Phase 3
Completed
Conditions
Macular Degeneration
Choroidal Neovascularization
Interventions
First Posted Date
2007-02-19
Last Posted Date
2011-04-19
Lead Sponsor
Novartis
Target Recruit Count
321
Registration Number
NCT00436553
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Novartis Investigative SIte, Royal Oak, Michigan, United States

๐Ÿ‡จ๐Ÿ‡ฆ

Ivey Eye Institute, Dr. Thomas Sheidow, London, Ontario, Canada

๐Ÿ‡บ๐Ÿ‡ธ

West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130, San Francisco, California, United States

and more 1 locations

Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

Phase 2
Terminated
Conditions
Macular Degeneration
Choroidal Neovascularization
Interventions
First Posted Date
2007-02-09
Last Posted Date
2011-04-21
Lead Sponsor
Novartis
Target Recruit Count
255
Registration Number
NCT00433017
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

Novartis Investigative site, Manchester, United Kingdom

The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

Phase 2
Completed
Conditions
Diabetic Macular Edema
Interventions
Procedure: Laser photocoagulation
Drug: Ranibizumab
First Posted Date
2006-12-05
Last Posted Date
2017-03-31
Lead Sponsor
Johns Hopkins University
Target Recruit Count
126
Registration Number
NCT00407381
Locations
๐Ÿ‡บ๐Ÿ‡ธ

East Bay Retina Consultants, Oakland, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Retina Institute of California, Pasadena, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

New England Retina Consultants, PC, West Springfield, Massachusetts, United States

and more 17 locations

Lucentis for Central Retinal Vein Occlusion (CRVO)

Phase 1
Completed
Conditions
Central Retinal Vein Occlusion
Interventions
First Posted Date
2006-12-04
Last Posted Date
2013-12-12
Lead Sponsor
California Retina Consultants
Target Recruit Count
20
Registration Number
NCT00406796
Locations
๐Ÿ‡บ๐Ÿ‡ธ

California Retina Consultants, Santa Maria, California, United States

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