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
-

Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration

First Posted Date
2010-07-05
Last Posted Date
2013-06-04
Lead Sponsor
Alcon Research
Target Recruit Count
99
Registration Number
NCT01157065
Locations
🇺🇸

Contact Alcon Call Center for Trial Locations, Fort Worth, Texas, United States

Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-06-03
Last Posted Date
2014-10-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
241
Registration Number
NCT01135914
Locations
🇨🇦

Memorial University Health Sciences Centre / Newfoundland Drive Medical Clinic, St-John's, Canada

🇨🇦

Dr.Michel Giunta Clinique Médicale, Sherbrooke, Quebec, Canada

🇨🇦

Saskatoon City Hospital / Spadina Clinic, Saskatoon, Saskatchewan, Canada

and more 17 locations

LUCAS (Lucentis Compared to Avastin Study)

First Posted Date
2010-05-20
Last Posted Date
2015-01-16
Lead Sponsor
Oslo University Hospital
Target Recruit Count
420
Registration Number
NCT01127360
Locations
🇳🇴

Department of Ophthalmology, Oslo University Hospital, Oslo, Norway

Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion

First Posted Date
2010-05-14
Last Posted Date
2010-05-14
Lead Sponsor
University of Pecs
Target Recruit Count
40
Registration Number
NCT01123564
Locations
🇭🇺

University of Pecs, Medical School, Department of Ophthalmology, Pecs, Hungary

🇭🇺

Debrecen Medical and Health Science Center Dept of Ophthalmology, Debrecen, Hungary

A Pilot Study to Evaluate the Role of High-dose Ranibizumab (2.0mg) in the Management of AMD in Patients With Persistent/Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy (the LAST Study)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-05-04
Last Posted Date
2018-05-03
Lead Sponsor
Vitreous -Retina- Macula Consultants of New York
Target Recruit Count
9
Registration Number
NCT01115556
Locations
🇺🇸

Vitreous Retina Macula Consultants of New York, New York, New York, United States

Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

First Posted Date
2010-04-13
Last Posted Date
2011-08-04
Lead Sponsor
University of Sao Paulo
Target Recruit Count
40
Registration Number
NCT01102946
Locations
🇧🇷

University of São Paulo, Ribeirao Preto, Sao Paulo, Brazil

Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-03-01
Last Posted Date
2017-04-28
Lead Sponsor
Johns Hopkins University
Target Recruit Count
152
Registration Number
NCT01077401
Locations
🇺🇸

Retina Group of Florida, Fort Lauderdale, Florida, United States

🇺🇸

Texas Retina Associates, Arlington, Texas, United States

🇺🇸

University of Kansas, Prairie Village, Kansas, United States

and more 10 locations

Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery

First Posted Date
2010-02-17
Last Posted Date
2012-10-04
Lead Sponsor
Bhagat, Neelakshi, M.D., M.P.H.
Target Recruit Count
4
Registration Number
NCT01069341
Locations
🇺🇸

Njms / Umdnj, Newark, New Jersey, United States

Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:

First Posted Date
2009-12-11
Last Posted Date
2018-07-27
Lead Sponsor
King's College Hospital NHS Trust
Target Recruit Count
25
Registration Number
NCT01030770
Locations
🇬🇧

Guy's & St. Thomas' Hospital NHS Foundatrion Trust, London, United Kingdom

🇬🇧

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

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