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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)

A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections

Completed
Conditions
Neovascular Age-Related Macular Degeneration
Interventions
First Posted Date
2020-12-10
Last Posted Date
2024-06-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
494
Registration Number
NCT04662944
Locations
🇪🇸

Novartis Investigative Site, Leon, Spain

A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

Phase 3
Recruiting
Conditions
Neovascular Age-related Macular Degeneration (nAMD)
Interventions
Device: Port Delivery System with Ranibizumab
First Posted Date
2020-12-08
Last Posted Date
2025-05-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
442
Registration Number
NCT04657289
Locations
🇮🇱

Rabin MC, Petach Tikva, Israel

🇮🇱

Kaplan Medical Center, Rehovot, Israel

🇮🇱

Tel Aviv Sourasky MC, Tel Aviv, Israel

and more 119 locations

Diabetic Macular Edema (DME) Treatment With Ranibizumab and Dexamethasone or Ranibizumab Only.

First Posted Date
2020-10-26
Last Posted Date
2020-10-26
Lead Sponsor
He Eye Hospital
Target Recruit Count
100
Registration Number
NCT04601675
Locations
🇨🇳

He Eye Specialist Hospital, Shenyang, Liaoning, China

Study of Zifibancimig in Participants With Neovascular Age-Related Macular Degeneration

Phase 1
Recruiting
Conditions
Macular Degeneration
Interventions
Device: Port Delivery Platform
First Posted Date
2020-09-28
Last Posted Date
2025-04-27
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
251
Registration Number
NCT04567303
Locations
🇺🇸

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

🇺🇸

Associated Retina Consultants, Phoenix, Arizona, United States

🇺🇸

The Retina Partners, Encino, California, United States

and more 43 locations

Intravitreal Ranibizumab in Recurrent ROP

Completed
Conditions
Retinopathy of Prematurity
First Posted Date
2020-09-04
Last Posted Date
2020-09-04
Lead Sponsor
Ameera Gamal Abdelhameed
Target Recruit Count
115
Registration Number
NCT04539106
Locations
🇪🇬

Mansoura University, Mansoura, Dakahlia, Egypt

Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

Phase 4
Conditions
Proliferative Diabetic Retinopathy
Diabetic Macular Edema
Interventions
Other: Sham injection
Procedure: Pars plana vitrectomy
First Posted Date
2020-07-09
Last Posted Date
2020-07-09
Lead Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Target Recruit Count
142
Registration Number
NCT04464694
Locations
🇨🇳

Eye & Ent Hospital of Fudan University, Shanghai, China

🇨🇳

Ningbo Eye Hospital, Ningbo, Zhejiang, China

🇨🇳

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine, Shanghai, China

Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)

Phase 2
Conditions
Ophthalmopathy
Interventions
First Posted Date
2020-07-07
Last Posted Date
2020-07-07
Lead Sponsor
Assiut University
Target Recruit Count
100
Registration Number
NCT04460001
Locations
🇪🇬

Wael, Asyut, Egypt

Combination of Ranibizumab and Targeted Laser Photocoagulation

Phase 3
Recruiting
Conditions
Central Retinal Vein Occlusion With Macular Edema
Interventions
Device: Laser photocoagulation
First Posted Date
2020-06-23
Last Posted Date
2025-03-26
Lead Sponsor
University of Giessen
Target Recruit Count
110
Registration Number
NCT04444492
Locations
🇩🇪

Universitätsklinikum Carl Gustav Carus Dresden Klinik und Polyklinik für Augenheilkunde, Dresden, Germany

🇩🇪

Internationale Innovative Ophthalmochirurgie GbR, Klinik für Augenchirurgie, Düsseldorf, Germany

🇩🇪

Universitätsklinikum Klinik für Augenheilkunde Freiburg, Freiburg, Germany

and more 12 locations

Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema

Completed
Conditions
Diabetic Macular Edema
Interventions
First Posted Date
2020-05-14
Last Posted Date
2020-05-14
Lead Sponsor
Centro Hospitalar do Porto
Target Recruit Count
50
Registration Number
NCT04387604
Locations
🇵🇹

Hospital de Santo António, Porto, Portugal

Evaluation of Retinal and Vascular Features in Radiation Maculopathy After Intravitreal Injections of Ranibizumab

Completed
Conditions
Radiation Maculopathy
First Posted Date
2020-05-06
Last Posted Date
2020-05-06
Lead Sponsor
Federico II University
Target Recruit Count
40
Registration Number
NCT04377295
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