{"id":"ranibizumab-refill-exchange","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Conjunctival hemorrhage"},{"rate":"5-10","effect":"Eye pain"},{"rate":"5-15","effect":"Floaters"},{"rate":"5-10","effect":"Intraocular pressure elevation"},{"rate":"0.05-0.1","effect":"Endophthalmitis"},{"rate":"0.1-0.5","effect":"Retinal detachment"}]},"_chembl":{"chemblId":"CHEMBL1201825","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ranibizumab blocks VEGF-A, a key driver of pathological neovascularization and increased vascular permeability in retinal diseases. By neutralizing VEGF-A, it prevents the formation of abnormal blood vessels and reduces fluid leakage, thereby slowing or halting vision loss in conditions characterized by excessive angiogenesis. The 'refill exchange' designation likely refers to a formulation or delivery system innovation rather than a mechanistic change.","oneSentence":"Ranibizumab is a monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A (VEGF-A), reducing abnormal blood vessel growth and vascular permeability in the eye.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:31:13.090Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Neovascular (wet) age-related macular degeneration"},{"name":"Diabetic macular edema"},{"name":"Retinal vein occlusion"},{"name":"Diabetic retinopathy"},{"name":"Myopic choroidal neovascularization"}]},"trialDetails":[{"nctId":"NCT04853251","phase":"PHASE4","title":"A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)","status":"RECRUITING","sponsor":"Genentech, Inc.","startDate":"2021-12-14","conditions":"Neovascular Age-related Macular Degeneration","enrollment":188},{"nctId":"NCT04108156","phase":"PHASE3","title":"A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2019-09-30","conditions":"Diabetic Macular Edema","enrollment":634},{"nctId":"NCT06847542","phase":"PHASE3","title":"A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2025-11-27","conditions":"Neovascular Age-related Macular Degeneration","enrollment":250},{"nctId":"NCT03683251","phase":"PHASE3","title":"Extension Study for the Port Delivery System With Ranibizumab (Portal)","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2018-09-20","conditions":"Neovascular Age-Related Macular Degeneration","enrollment":1000},{"nctId":"NCT04503551","phase":"PHASE3","title":"A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2020-08-10","conditions":"Diabetic Retinopathy","enrollment":174},{"nctId":"NCT04657289","phase":"PHASE3","title":"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)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2021-07-14","conditions":"Neovascular Age-related Macular Degeneration (nAMD)","enrollment":451},{"nctId":"NCT05562947","phase":"PHASE3","title":"A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2024-06-17","conditions":"Neovascular Age-related Macular Degeneration, nAMD","enrollment":68},{"nctId":"NCT03677934","phase":"PHASE3","title":"A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2018-09-12","conditions":"Neovascular Age-Related Macular Degeneration","enrollment":415}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Ranibizumab refill exchange","genericName":"Ranibizumab refill exchange","companyName":"Hoffmann-La Roche","companyId":"roche","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ranibizumab is a monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A (VEGF-A), reducing abnormal blood vessel growth and vascular permeability in the eye. Used for Neovascular (wet) age-related macular degeneration, Diabetic macular edema, Retinal vein occlusion.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}