Iontophoresis is a method of using a mild electrical current to enhance the penetration of a drug through tissue. Our long term goal is to develop the Visulex(r) ocular iontophoresis device capable of delivering large molecule anti-VEGF agents to the posterior segment of the eye: * A safe, noninvasive ocular drug delivery method, thereby improving patient compliance. * A system operated by nurses, paraprofessionals, or even patient themselves, making anti- VEGF therapy more accessible to AMD patients thereby improving vision and quality of life for a greater portion of our population. * Cost effective for our health c are system by minimizing the need for complicated procedures (i.e. laser or surgical procedures) handled by retinal specialists. * Dosing of anti-VEGF therapy can be adjusted by incorporating or varying iontophoresis parameters (e.g. current density or treatment duration); drug formulations (e.g. incorporation of electroosmosis enhancers); or electroporation methods. * Changing a treatment paradigm for AMD both in terms of addressing acute conditions and those borderline cases such as early stages of the dry form of AMD where only prevention treatment measures to inhibit AMD are warranted. * The risks associated with frequent treatments addressing chronic AMD therapy would be less than IVT injections. To achieve proof of concept of this goal, we will conduct this project under three specific aims: 1) To optimize the iontophoretic parameters for an ocular delivery system of both Avastin(r) and Lucentis(r) in vitro. 2) To study the pharmacokinetics and assess the local tolerance of the eye following iontophoretic administration of the drugs in vivo in rabbit. 3) To establish transscleral iontophoresis of Avastin(r) and Lucentis(r) for the treatment of choroidal neovascularization in a disease treatment model.
Public Health Relevance: Our phase I business catalyst grant proposes to develop a non-invasive, topical ocular drug delivery system using a mild electrical current methodology allowing for a timely application procedure in the doctor's office of a device (resembling a scleral lens) which eventually can be performed by a nurse or paraprofessional. Age-related macular degeneration (AMD) is a leading cause of blindness in the United States. While anti-VEGF compounds Avastin(r) and Lucentis(r) are effective in the treatment of the wet (acute, sight threatening) form of AMD, they must be administered frequently by intravitreal (IVT) injections. IVT injections involve a number of serious risks including retinal detachment, endophthalmitis, increased IOP and cataractogenesis. Frequent intraocular injections are not patient friendly and burdens our health care system with expensive procedures as they also take up a great deal of time out of the schedules of retinal specialists who are limited in numbers in the United States (less than 2500).
Thesaurus Terms: Acute; Address; Adverse Effects; After Care; After-Treatment; Aftercare; Age Related Macular Degeneration; Anti-Vegf; Anti-Vegf Humanized Monoclonal Antibody; Anti-Vegf Rhumab; Application Procedure; Area; Avastin; Back; Bevacizumab (Rhumab Vegf); Blindness; Body Tissues; Businesses; Cataract; Choroidal Neovascularization; Chronic; Compliance Behavior; Convection; Device Designs; Devices; Disease; Disorder; Dorsum; Dose; Drug Administration, Topical; Drug Delivery; Drug Delivery Systems; Drug Formulations; Drug Iontophoresis; Drug Kinetics; Drug Targeting; Drug Targetings; Drugs; Electromagnetic, Laser; Electrophoresis; Electroporation; Endophthalmitis; Enhancers; Eye; Eye Exam; Eye Examination; Eye Diseases; Eyeball; Formulation; Formulations, Drug; Foundations; Fractionation, Electrophoretic; Goals; Grant; Health; Health Care Costs; Health Costs; Healthcare Costs; Healthcare Systems; In Vitro; Injection Of Therapeutic Agent; Injections; Iontophoresis; Lasers; Lucentis; Mr Imaging; Mr Tomography; Mri; Maculopathy, Age-Related; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; Mammals, Rabbits; Measures; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Medication; Method Loinc Axis 6; Methodology; Methods; Methods And Techniques; Methods, Other; Moab Vegf; Modeling; Monoclonal Antibody Anti-Vegf; Nmr Imaging; Nmr Tomography; Neovascularization, Choroid; Nuclear Magnetic Resonance Imaging; Nurses; Operating System; Operation; Operative Procedures; Operative Surgical Procedures; Ophthalmia; Ophthalmic Examination And Evaluation; Ophthalmologist; Oryctolagus Cuniculus; Patient Compliance; Patient Cooperation; Patients; Penetration; Personnel, Nursing; Pharmaceutic Preparations; Pharmaceutical Preparations; Pharmacokinetics; Phase; Population; Posterior Eye Segment; Posterior Eyeball Segment Structure; Prevention; Prevention Measures; Procedures; Property; Property, Loinc Axis 2; Prophylactic Treatment; Prophylaxis; Qol; Quality Of Life; Rabbit, Domestic; Rabbits; Radiation, Laser; Recombinant Humanized Anti-Vegf Monoclonal Antibody; Recombinant Humanized Monoclonal Antibody To Vascular Endothelial Growth Factor; Retinal; Retinal Detachment; Rhumab Vegf; Risk; Sched; Safety; Schedule; Sclera; Sight; Specialist; Staging; Surface; Surgical; Surgical Interventions; Surgical Procedure; System; System, Loinc Axis 4; Systems, Health Care; Techniques; Time; Tissues; Topical Application; Treatment Compliance; Treatment Period; Treatment Side Effects; United States; Vision; White Of Eye; Zeugmatography; Bevacizumab; Catalyst; Cataractogenesis; Cataractous Lenses; Comparative; Compliance Cooperation; Conjunctiva; Cost Effective; Density; Disease/Disorder; Drug/Agent; Electric Field; Experiment; Experimental Research; Experimental Study; Eye Disorder; Improved; In Vivo; Iontophoresis Therapy; Lens; Macromolecule; Molecular Size; Novel; Ophthalmopathy; Patient Adherence; Public Health Relevance; Research Study; Retina Detachment; Rhumabvegf; Senile Macular Disease; Side Effect; Surgery; Therapy Adverse Effect; Therapy Compliance; Therapy Cooperation; Topical Administration; Topical Drug Application; Topically Applied; Treatment Adverse Effect; Treatment Days; Treatment Duration
