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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)

Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD

Phase 1
Completed
Conditions
Wet Age-related Macular Degeneration
Interventions
First Posted Date
2021-05-13
Last Posted Date
2024-03-28
Lead Sponsor
Shanghai Biomabs Pharmaceutical Co., Ltd.
Target Recruit Count
24
Registration Number
NCT04884399
Locations
🇨🇳

Beijing Tongren Hospital, Beijing, Beijing, China

🇨🇳

Peking University People'S Hospital, Beijing, Beijing, China

🇨🇳

Renmin Hospital of Wuhan University, Wuhan, Hubei, China

and more 1 locations

A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration

Phase 3
Completed
Conditions
Neovascular(Wet) Age Related Macular Degeneration
Interventions
First Posted Date
2021-04-23
Last Posted Date
2021-04-23
Lead Sponsor
Chong Kun Dang Pharmaceutical
Target Recruit Count
312
Registration Number
NCT04857177
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration(nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

Phase 4
Recruiting
Conditions
Neovascular Age-related Macular Degeneration
Interventions
Device: SUSVIMO PDS Implant
First Posted Date
2021-04-21
Last Posted Date
2025-05-13
Lead Sponsor
Genentech, Inc.
Target Recruit Count
188
Registration Number
NCT04853251
Locations
🇺🇸

Barnet Dulaney Perkins Eye Center, Mesa, Arizona, United States

🇺🇸

California Retina Consultants, Bakersfield, California, United States

🇺🇸

Retina Associates of Southern California, Huntington Beach, California, United States

and more 46 locations

Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications

Completed
Conditions
Neovascular (Wet) Age-related Macular Degeneration
Interventions
First Posted Date
2021-04-19
Last Posted Date
2021-04-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
5500
Registration Number
NCT04847895
Locations
🇨🇭

Novartis Investigative Site, Zurich, Switzerland

OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)

Phase 3
Terminated
Conditions
Neovascular Age-related Macular Degeneration
Interventions
Biological: 2.0 mg OPT-302
Procedure: Sham
First Posted Date
2021-02-17
Last Posted Date
2025-04-18
Lead Sponsor
Opthea Limited
Target Recruit Count
986
Registration Number
NCT04757610
Locations
🇧🇷

ShORe Investigational site, Blumenau, Santa Catarina, Brazil

🇮🇹

ShORe Investiagational Site, Genova, Italy

🇺🇸

ShORe Investiagtional Site, Poway, California, United States

and more 1 locations

A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

Phase 3
Completed
Conditions
Age Related Macular Degeneration
Interventions
First Posted Date
2021-02-05
Last Posted Date
2025-01-03
Lead Sponsor
Shanghai Henlius Biotech
Target Recruit Count
410
Registration Number
NCT04740671
Locations
🇸🇰

Fakultna Nemocnica S Poliklinikou Nove Zamky Oftalmologicke Nelozkove Oddelenie, Nové Zámky, Slovakia

🇪🇸

Instituto Oftalmologico Fernandez-Vega, Oviedo, Spain

🇺🇸

Associated Retina Consultants-Gilbert, Gilbert, Arizona, United States

and more 120 locations

OCTA and Polypoidal Choroidal Vasculopathy

Completed
Conditions
Polypoidal Choroidal Vasculopathy
Interventions
First Posted Date
2021-01-19
Last Posted Date
2021-01-19
Lead Sponsor
Federico II University
Target Recruit Count
60
Registration Number
NCT04714242
Locations
🇮🇹

University of Naples "Federico II", Naples, Italy

Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

Phase 2
Recruiting
Conditions
AMD
nAMD
Wet Age-related Macular Degeneration
Neovascular AMD
wAMD
Wet AMD
CNV
Neovascular Age-related Macular Degeneration
Choroidal Neovascularization
Interventions
Genetic: ABBV-RGX-314
Genetic: RGX-314
First Posted Date
2021-01-12
Last Posted Date
2025-01-29
Lead Sponsor
AbbVie
Target Recruit Count
540
Registration Number
NCT04704921
Locations
🇺🇸

170-Barnet Dulaney Perkins Eye Center, Sun City, Arizona, United States

🇺🇸

188-Colorado Retina Associates (CRA) - Red Rocks Medical Center Location, Lakewood, Colorado, United States

🇺🇸

291-The Retina Institute, Saint Louis, Missouri, United States

and more 88 locations

Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation

First Posted Date
2021-01-07
Last Posted Date
2022-08-10
Lead Sponsor
Faculty Hospital Kralovske Vinohrady
Registration Number
NCT04698850
Locations
🇨🇿

Department of Ophthalmology, Faculty hospital Kralovske Vinohrady, Prague, Czechia

Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD

Phase 3
Completed
Conditions
Neovascular Age-related Macular Degeneration
Interventions
Drug: LUBT010 (proposed ranibizumab biosimilar)
First Posted Date
2020-12-30
Last Posted Date
2024-08-07
Lead Sponsor
Lupin Ltd.
Target Recruit Count
600
Registration Number
NCT04690556
Locations
🇮🇳

Mysore Medical College and Research Institute, Mysore, Karnataka, India

🇮🇳

JSS Hospital, Mysore, Karnataka, India

🇮🇳

Aakash Healthcare Super Specialty Hospital, New Delhi, India

and more 23 locations
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