Patients of either sex, 50 years of age or older, with a diagnosis of Choroidal Neovascularization CNV due to Age-Related Macular Degeneration AMD in the study eye
Conditions
Interventions
Product Name: Pazopanib
Pharmaceutical Form: Eye drops, solution in single-dose container
Trade Name: Lucentis - Ranibizumab
Product Name: Lucentis
Sponsors
ForSight VISION4, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 50 years of age or older 2. Capable of understanding the requirements of the study, willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits. 3. Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography for which anti-VEGF intraocular injection is indicated (> 25% active disease with =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Prior vitrectomy in the study eye 2. Any periocular/intraocular injections in the study eye in the past 2 months. 3. Any ophthalmic surgery performed on the study eye within the past 1 month 4. Recent or current evidence of ocular infection or inflammation in either eye. 5. Use of anticoagulant, non-inclusive of non-steroidal anti-inflammatory agents (NSAID) or aspirin, within 14 days of enrollment 6. Uncontrolled glaucoma defined as IOP greater than 25 mm Hg. 7. Hypotony (defined as IOP of 5 mm Hg or less) 8. Uncontrolled hypertension, systolic BP > 155 mm Hg. 9. Uncontrolled systemic disease (eg, diabetes, hypertension, etc.) that in the opinion of the Investigator could confound the study outcomes or prevent the patient from completing the study 10. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational product. 11. Known intolerance or hypersensitivity to any component of the investigational drug or ranibizumab formulations to be used (eg, polyvinylpyrrolidone [PVP], cyclodextrins), components of the drug delivery device (polymethyl methacrylate [PMMA], titanium, silicone), or to topical anesthetics, mydriatics or antibiotics. 12. Females who are pregnant or nursing and women of childbearing potential who are not using adequate contraceptive precautions (eg, intrauterine device, oral contraceptives, barrier method or other contraception deemed adequate by the Investigator) 13. Have angioid streaks, presumed ocular hisoplasmosis syndrome, myopia (> 8 diopters) or CNV secondary to other causes than AMD 14. Any additional ocular disease, which may have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, or diabetic retinopathy 15. Inability to obtain photographs, fluorescein angiography (FA) or OCT to document CNV, eg, due to media opacity, allergy to fluorescein dye or lack of venous access 16. Any condition that, in the opinion of the investigator, would jeopardize the safety of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the ocular and systemic safety of sustained intraocular pazopanib delivery from the V406 PDS Implant in patients with choroidal neovascularization(CNV) due to age-related macular degeneration (AMD);Secondary Objective: • To determine the preliminary efficacy of sustained intraocular pazopanib delivery as assessed by macular thickness reduction measured by Optical Coherence Tomography (OCT).; Primary end point(s): Primary Efficacy Variable: • Absolute change from baseline in Central Subfield Foveal Thickness (CSFT) in the study eye as measured by OCT at Week 4 following dosing initiation (Week 4 in ranibizumab injection group and Week 6 in V406 PDS group) ;Timepoint(s) of evaluation of this end point: 4 and 6 weeks from study initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Variable: • Absolute and percent change from baseline in CSFT and mean change in best corrected visual acuity (BCVA) from baseline at Weeks 4, 12, and 24 following dosing initiation. ;Timepoint(s) of evaluation of this end point: 4, 12 and 24 weeks from study initation | — |
Countries
Latvia
Contacts
Public ContactOleg Polnjak
Clinical Research Foundation
Outcome results
None listed