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
-

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-05-03
Last Posted Date
2016-05-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
181
Registration Number
NCT01846299
Locations
🇬🇧

Novartis Investigative Site, Sunderland, United Kingdom

Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.

First Posted Date
2013-04-25
Last Posted Date
2016-08-26
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
183
Registration Number
NCT01840410
Locations
🇹🇷

Novartis Investigative Site, Kocaeli, Turkey

Intravitreal tPA and C3F8 for the Treatment of Submacular Haemorrhage as a Complication of Neovascular AMD

First Posted Date
2013-04-18
Last Posted Date
2020-07-14
Lead Sponsor
King's College Hospital NHS Trust
Target Recruit Count
55
Registration Number
NCT01835067
Locations
🇬🇧

Hull & East Yorkshire Hospital NHS Trust, Hull, United Kingdom

🇬🇧

King's College Hospital NHS Foundation Trust, London, United Kingdom

🇬🇧

Southend University Hospital NHS Foundation Trust, Southend, United Kingdom

and more 2 locations

Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion

First Posted Date
2013-04-10
Last Posted Date
2015-12-14
Lead Sponsor
Valley Retina Institute
Target Recruit Count
45
Registration Number
NCT01827722
Locations
🇺🇸

Retina Associates, Lakeland, Florida, United States

🇺🇸

Retina Vitreous Associates Medical Group, Beverly Hills, California, United States

🇺🇸

Valley Retina Institute, PA, McAllen, Texas, United States

and more 1 locations

Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-04-04
Last Posted Date
2016-03-30
Lead Sponsor
Poitiers University Hospital
Target Recruit Count
35
Registration Number
NCT01823965
Locations
🇫🇷

Chu de Poitiers, Poitiers, France

Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

First Posted Date
2013-03-13
Last Posted Date
2016-05-04
Lead Sponsor
Pusan National University Hospital
Target Recruit Count
49
Registration Number
NCT01810042
Locations
🇰🇷

Pusan National University Hospital, Busan, Korea, Republic of

🇰🇷

Haeundae Baik Hospital, Busan, Korea, Republic of

Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision

First Posted Date
2013-02-20
Last Posted Date
2019-09-19
Lead Sponsor
Seoul National University Bundang Hospital
Target Recruit Count
19
Registration Number
NCT01795209
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Gyunggi-do, Korea, Republic of

🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

First Posted Date
2013-01-31
Last Posted Date
2017-08-14
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
671
Registration Number
NCT01780935
Locations
🇬🇧

Novartis Investigative Site, York, United Kingdom

Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)

First Posted Date
2013-01-24
Last Posted Date
2019-09-04
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
332
Registration Number
NCT01775124
Locations
🇨🇳

Novartis Investigative Site, Shanghai, China

© Copyright 2024. All Rights Reserved by MedPath