2010
Phase 1 Study of Aflibercept Administered Subcutaneously to Patients with Advanced Solid Tumors
Tew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 Study of Aflibercept Administered Subcutaneously to Patients with Advanced Solid Tumors. Clinical Cancer Research 2010, 16: 358-366. PMID: 20028764, PMCID: PMC4211604, DOI: 10.1158/1078-0432.ccr-09-2103.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsDrug-related grade 3Vascular endothelial growth factor trapDose of afliberceptDose-escalation studyDose-proportional increaseInjection site reactionsPhase 1 studyManageable side effectsVascular endothelial growth factorWarrants further evaluationFavorable pharmacokinetic profileProgression of diseaseNovel antiangiogenic agentsEndothelial growth factorCommon toxicitiesStable diseasePulmonary embolismCerebral ischemiaSubcutaneous dosesSafety profileSingle doseSite reactionsSubcutaneous formulation
2009
A Phase I Study of Intravitreal Vascular Endothelial Growth Factor Trap-Eye in Patients with Neovascular Age-Related Macular Degeneration
Nguyen QD, Shah SM, Browning DJ, Hudson H, Sonkin P, Hariprasad SM, Kaiser P, Slakter JS, Haller J, V. D, Mieler WF, Chu K, Yang K, Ingerman A, Vitti RL, Berliner AJ, Cedarbaum JM, Campochiaro PA. A Phase I Study of Intravitreal Vascular Endothelial Growth Factor Trap-Eye in Patients with Neovascular Age-Related Macular Degeneration. Ophthalmology 2009, 116: 2141-2148.e1. PMID: 19700196, DOI: 10.1016/j.ophtha.2009.04.030.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overChoroidal NeovascularizationFemaleFluorescein AngiographyFollow-Up StudiesHumansInjectionsMacular DegenerationMaleMaximum Tolerated DoseReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTomography, Optical CoherenceTreatment OutcomeVisual AcuityVitreous BodyConceptsVEGF Trap-EyeAge-related macular degenerationVascular endothelial growth factor (VEGF) Trap-EyeNeovascular age-related macular degenerationNeovascular AMDChoroidal neovascularizationOptical coherence tomographyFoveal thicknessIntravitreal injectionVisual acuityMacular degenerationMean increaseArea of CNVExcess foveal thicknessSingle intraocular injectionPrimary end pointSerious adverse eventsPhase III trialsHigh-dose groupInterventional clinical trialsActive choroidal neovascularizationNumber of patientsHuman immunoglobulin G (IgG) FcVEGF receptor 1VEGF family membersAn exploratory study of the safety, tolerability and bioactivity of a single intravitreal injection of vascular endothelial growth factor Trap-Eye in patients with diabetic macular oedema
V D, Nguyen QD, Shah SM, Browning DJ, Haller JA, Chu K, Yang K, Cedarbaum JM, Vitti RL, Ingerman A, Campochiaro PA. An exploratory study of the safety, tolerability and bioactivity of a single intravitreal injection of vascular endothelial growth factor Trap-Eye in patients with diabetic macular oedema. British Journal Of Ophthalmology 2009, 93: 144. PMID: 19174400, DOI: 10.1136/bjo.2008.138271.Peer-Reviewed Original ResearchConceptsVEGF Trap-EyeDiabetic macular edemaSingle intravitreal injectionVascular endothelial growth factor (VEGF) Trap-EyeExcess foveal thicknessFoveal thicknessIntravitreal injectionOptical coherence tomographyMacular edemaUnrelated serious adverse eventsMedian baseline BCVASerious adverse eventsBaseline BCVAETDRS lettersAdverse eventsRetinal thicknessVisual acuityOcular toxicityOutcome measuresBCVAMedian improvementPatientsCoherence tomographyAdditional studiesObservation period
2006
Dynamic and Quantitative Analysis of Choroidal Neovascularization by Fluorescein Angiography
Shah SM, Tatlipinar S, Quinlan E, Sung JU, Tabandeh H, Nguyen QD, Fahmy AS, Zimmer-Galler I, Symons RC, Cedarbaum JM, Campochiaro PA. Dynamic and Quantitative Analysis of Choroidal Neovascularization by Fluorescein Angiography. Investigative Ophthalmology & Visual Science 2006, 47: 5460-5468. PMID: 17122137, DOI: 10.1167/iovs.06-0012.Peer-Reviewed Original ResearchConceptsFluorescein angiographyFluorescein angiogramsClinical trialsVEGF TrapVascular endothelial growth factor trapPlacebo-treated patientsPhotodynamic therapyChoroidal neovascularization lesion sizeAreas of hyperfluorescenceMacular volumeChoroidal neovascularizationRetrospective gradingOutcome measuresGroup 2Group 1Masked observersPatientsFluorescence areaLesion sizeAngiogramsClinical settingDye injectionInitial assessmentAUCTrialsA Phase I Trial of an IV-Administered Vascular Endothelial Growth Factor Trap for Treatment in Patients with Choroidal Neovascularization due to Age-Related Macular Degeneration
Nguyen QD, Shah SM, Hafiz G, Quinlan E, Sung J, Chu K, Cedarbaum JM, Campochiaro PA, Group C. A Phase I Trial of an IV-Administered Vascular Endothelial Growth Factor Trap for Treatment in Patients with Choroidal Neovascularization due to Age-Related Macular Degeneration. Ophthalmology 2006, 113: 1522.e1-1522.e14. PMID: 16876249, DOI: 10.1016/j.ophtha.2006.05.055.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overChoroidal NeovascularizationDose-Response Relationship, DrugFemaleFluorescein AngiographyHumansInfusions, IntravenousMacular DegenerationMaleMaximum Tolerated DoseMiddle AgedReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsRetinaTomography, Optical CoherenceVisual AcuityConceptsVascular endothelial growth factor trapAge-related macular degenerationVEGF TrapRetinal thicknessVisual acuityMacular degenerationEarly Treatment Diabetic Retinopathy Study protocolNeovascular age-related macular degenerationDiabetic Retinopathy Study protocolPlacebo-controlled clinical trialDoses 2 weeksDose-limiting toxicityPhase I trialMean percent changeVEGF receptor 1Optical coherence tomographyAdverse eventsI trialDose groupChoroidal neovascularizationStudy protocolClinical trialsStudy populationMultiple administrationsTherapeutic window