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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
-

Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy

Phase 4
Conditions
Wet Macular Degeneration
Interventions
First Posted Date
2016-06-21
Last Posted Date
2018-11-30
Lead Sponsor
Aier School of Ophthalmology, Central South University
Target Recruit Count
120
Registration Number
NCT02806752
Locations
🇨🇳

Wuhan General Hospital of PLA, Wuhan, Hubei, China

🇨🇳

The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

🇨🇳

Shenzhen Aier Eye Hospital, Shenzhen, Guangdong, China

and more 4 locations

Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

Phase 3
Conditions
Age-related Macular Degeneration
Interventions
First Posted Date
2016-04-05
Last Posted Date
2017-04-27
Lead Sponsor
Ohr Pharmaceutical Inc.
Target Recruit Count
230
Registration Number
NCT02727881
Locations
🇺🇸

Investigational Site, Madison, Wisconsin, United States

Cytokeratin 8 Level in Age-related Macular Degeneration

Completed
Conditions
Age-related Macular Degeneration
Interventions
First Posted Date
2016-03-14
Last Posted Date
2020-12-09
Lead Sponsor
Gangnam Severance Hospital
Target Recruit Count
58
Registration Number
NCT02707575
Locations
🇰🇷

Inje University Ilsan Paik Hospital, Goyang, Korea, Republic of

🇰🇷

Gangnam Severance Hospital, Seoul, Korea, Republic of

A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema

Phase 2
Completed
Conditions
Diabetic Macular Edema
Interventions
First Posted Date
2016-03-04
Last Posted Date
2020-09-25
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
229
Registration Number
NCT02699450
Locations
🇺🇸

United Med Res Inst, Inglewood, California, United States

🇺🇸

Ophthalmic Clinical Trials San Diego, Oceanside, California, United States

🇺🇸

Southern CA Desert Retina Cons, Palm Desert, California, United States

and more 56 locations

A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS)

Phase 3
Completed
Conditions
Macular Edema
Interventions
First Posted Date
2016-03-03
Last Posted Date
2017-09-21
Lead Sponsor
Genentech, Inc.
Target Recruit Count
35
Registration Number
NCT02698566
Locations
🇺🇸

Southeastern Retina Associates, Chattanooga, Tennessee, United States

🇺🇸

Char Eye Ear &Throat Assoc, Charlotte, North Carolina, United States

🇺🇸

Paducah Retinal Center, Paducah, Kentucky, United States

and more 1 locations

Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab

Phase 4
Terminated
Conditions
Visual Acuity Reduced Transiently
Macular Edema, Cystoid
Interventions
First Posted Date
2016-01-28
Last Posted Date
2019-11-20
Lead Sponsor
Prof. Dr. Antonia M. Joussen
Target Recruit Count
4
Registration Number
NCT02665689
Locations
🇩🇪

Department of Ophthalmology, Charite, Berlin, Berlin, Germany

Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema

First Posted Date
2016-01-06
Last Posted Date
2016-01-06
Lead Sponsor
Instituto de Olhos de Goiania
Target Recruit Count
20
Registration Number
NCT02646670

Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma

Phase 4
Completed
Conditions
Diabetic Retinopathy
Glaucoma, Neovascular
Interventions
First Posted Date
2016-01-06
Last Posted Date
2016-01-06
Lead Sponsor
Ruijin Hospital
Target Recruit Count
18
Registration Number
NCT02647515

Rainbow Extension Study

Phase 3
Completed
Conditions
Retinopathy of Prematurity (ROP)
Interventions
First Posted Date
2015-12-29
Last Posted Date
2023-02-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
180
Registration Number
NCT02640664
Locations
🇬🇧

Novartis Investigative Site, Portsmouth, United Kingdom

Intravitreal Aflibercept or Ranibizumab for Rubeosis Iridis

Phase 3
Completed
Conditions
Rubeosis Iridis
Glaucoma
Interventions
First Posted Date
2015-12-29
Last Posted Date
2015-12-29
Lead Sponsor
Instituto de Olhos de Goiania
Target Recruit Count
2
Registration Number
NCT02641457
Locations
🇧🇷

Instituto de Olhos de Goiania, Goiania, GO, Brazil

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