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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)

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
🇬🇧

Novartis Investigative site, Manchester, United Kingdom

Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

Phase 3
Completed
Conditions
Choroidal Neovascularization
Age-Related Macular Degeneration
Interventions
First Posted Date
2007-02-01
Last Posted Date
2009-04-07
Lead Sponsor
University Hospital, Basel, Switzerland
Target Recruit Count
40
Registration Number
NCT00429962
Locations
🇨🇭

University Eye Clinic, Basel, Basel-Stadt, Switzerland

Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

Phase 1
Completed
Conditions
Polypoidal Choroidal Vasculopathy
Interventions
First Posted Date
2007-01-19
Last Posted Date
2014-11-05
Lead Sponsor
Hawaii Pacific Health
Target Recruit Count
17
Registration Number
NCT00424710
Locations
🇺🇸

The Retina Center at Pali Momi, Aiea, Hawaii, United States

🇺🇸

Retina Consultants of Hawaii, Honolulu, Hawaii, United States

Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration

Phase 4
Terminated
Conditions
Age-Related Macular Degeneration
Interventions
First Posted Date
2007-01-18
Last Posted Date
2016-03-04
Lead Sponsor
David M. Brown, M.D.
Target Recruit Count
7
Registration Number
NCT00423189
Locations
🇺🇸

Vitreoretinal Consultants, Houston, Texas, United States

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

Phase 2
Completed
Conditions
Diabetic Macular Edema
Interventions
Procedure: Laser photocoagulation
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
🇺🇸

East Bay Retina Consultants, Oakland, California, United States

🇺🇸

Retina Institute of California, Pasadena, California, United States

🇺🇸

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
🇺🇸

California Retina Consultants, Santa Maria, California, United States

Rubeosis Anti-VEGF (RAVE) Trial for Ischemic Central Retinal Vein Occlusion

Phase 1
Completed
Conditions
Ischemic Central Retinal Vein Occlusion
Interventions
First Posted Date
2006-12-04
Last Posted Date
2013-03-14
Lead Sponsor
Greater Houston Retina Research
Target Recruit Count
20
Registration Number
NCT00406471
Locations
🇺🇸

Vitreoretinal Consultants, Houston, Texas, United States

Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

Phase 1
Completed
Conditions
Retinal Vein Occlusion
Interventions
First Posted Date
2006-11-23
Last Posted Date
2016-01-01
Lead Sponsor
Vitreous -Retina- Macula Consultants of New York
Target Recruit Count
41
Registration Number
NCT00403039
Locations
🇺🇸

Vitreous Retina Macula Consultants of New York, P.C., New York City, New York, United States

Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

Phase 1
Completed
Conditions
Macular Degeneration
Interventions
First Posted Date
2006-11-03
Last Posted Date
2009-02-09
Lead Sponsor
The National Retina Institute
Target Recruit Count
20
Registration Number
NCT00395707
Locations
🇺🇸

National Retina Institute, Towson, Maryland, United States

Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.

Phase 1
Completed
Conditions
Choroidal Neovascularization
Interventions
First Posted Date
2006-11-03
Last Posted Date
2010-01-08
Lead Sponsor
Ophthalmic Consultants of Boston
Target Recruit Count
30
Registration Number
NCT00395551
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