MedPath

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)

A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Phase 2
Recruiting
Conditions
Diabetic Macular Edema (DME)
Interventions
First Posted Date
2025-05-04
Last Posted Date
2025-05-04
Lead Sponsor
EyeBiotech Ltd.
Target Recruit Count
960
Registration Number
NCT06957080
Locations
🇺🇸

Bakersfield, CA, Bakersfield, California, United States

🇺🇸

Modesto, CA, Modesto, California, United States

🇺🇸

Redlands, CA, Redlands, California, United States

and more 36 locations

Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)

Phase 3
Recruiting
Conditions
Wet Age-related Macular Degeneration
Interventions
First Posted Date
2025-04-30
Last Posted Date
2025-05-04
Lead Sponsor
Parc de Salut Mar
Target Recruit Count
630
Registration Number
NCT06952452
Locations
🇪🇸

Hospital Universitario de Canarias, La Laguna, Santa Cruz De Tenerife, Spain

🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

🇪🇸

Hospital la Esperanza, Barcelona, Spain

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD

Phase 3
Not yet recruiting
Conditions
Neovascular Age-related Macular Degeneration
Interventions
Device: Susvimo PDS Implant
First Posted Date
2025-02-26
Last Posted Date
2025-05-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
250
Registration Number
NCT06847542

A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema

Phase 1
Completed
Conditions
Diabetic Macular Edema
Uveitic Macular Edema
Interventions
First Posted Date
2025-01-13
Last Posted Date
2025-01-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
85
Registration Number
NCT06771271
Locations
🇺🇸

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

🇺🇸

Retina Institute of California Medical Group d/b/a Acuity Eye Group, Palm Desert, California, United States

🇺🇸

Byers Eye Insitute at Stanford, Palo Alto, California, United States

and more 16 locations

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Phase 2
Recruiting
Conditions
Diabetic Macular Edema (DME)
Interventions
First Posted Date
2024-08-26
Last Posted Date
2025-05-20
Lead Sponsor
EyeBiotech Ltd.
Target Recruit Count
960
Registration Number
NCT06571045
Locations
🇸🇰

Zilina, Slovakia, Žilina, Slovakia

🇺🇸

Scottsdale, Scottsdale, Arizona, United States

🇺🇸

Fayetteville, Arkansas, Fayetteville, Arkansas, United States

and more 150 locations

A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema

Phase 3
Recruiting
Conditions
Diabetic Macular Edema
Retinal Disease
Macular Edema
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Interventions
First Posted Date
2024-03-12
Last Posted Date
2025-03-06
Lead Sponsor
Incepta Pharmaceuticals Ltd
Target Recruit Count
70
Registration Number
NCT06305416
Locations
🇧🇩

Bangladesh Eye Hospital & Institute, Dhaka, Bangladesh

Relationship Between Dyslipidemia and The Response of Diabetic Macular Edema to Intravitreal Injection of Anti Vascular Endothelial Growth Factor Agents

Early Phase 1
Recruiting
Conditions
Diabetic Macular Edema
First Posted Date
2024-01-16
Last Posted Date
2024-01-16
Lead Sponsor
Sohag University
Target Recruit Count
50
Registration Number
NCT06205979
Locations
🇪🇬

Sohag university Hospital, Sohag, Egypt

A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Phase 3
Completed
Conditions
Wet Macular Degeneration
Age-Related Macular Degeneration
Neovascular Age-related Macular Degeneration
Interventions
First Posted Date
2024-01-05
Last Posted Date
2025-02-25
Lead Sponsor
Outlook Therapeutics, Inc.
Target Recruit Count
400
Registration Number
NCT06190093
Locations
🇺🇸

Clinical Site, Silverdale, Washington, United States

A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

Phase 3
Recruiting
Conditions
Choroidal Neovascularization Secondary to Pathologic Myopia
Interventions
Procedure: Sham Procedure
First Posted Date
2023-12-19
Last Posted Date
2025-05-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
280
Registration Number
NCT06176352
Locations
🇫🇷

Chi De Creteil, Creteil, France

🇫🇷

Pole Vision Val d'Ouest, Ecully, France

🇵🇱

Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o., ?ód?, Poland

and more 73 locations

Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity

Phase 3
Completed
Conditions
Ranibizumab
Retina Disease
Retinopathy of Prematurity
Interventions
First Posted Date
2023-01-27
Last Posted Date
2023-01-30
Lead Sponsor
Zagazig University
Target Recruit Count
30
Registration Number
NCT05701124
Locations
🇪🇬

Zagazig University, Faculty of medicine, Zagazig, Egypt

© Copyright 2025. All Rights Reserved by MedPath