Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) is among the leading causes of blindness in the world. The primary treatment modality is injection of Lucentis into the vitreous. Such treatment maintains baseline vision in ~90% of patients and improves vision in ~40% of patients and has thus become the first treatment of choice for this disease.
Conditions
Sponsors
Forsight Vision 4, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients at least 50 years of age who meet the following entry criteria will be eligible for enrollment in this study: 1. Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated, and 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
Exclusion criteria
Exclusion criteria: Patients with the following characteristics will be excluded from the study: 1. Evidence of scarring CNV (e.g. geographic atrophy) in the study eye 2. Fibrosis =75% of lesion area in the study eye 3. Vision better than 20/50 in the study eye 4. Any ophthalmic surgery performed on the study eye within three (3) months prior to study 5. Any prior treatment with an anti-VEGF agent (i.e. Lucentis, Avastin, Macugen, VEGF Trap-Eye) in the study eye 6. Prior vitrectomy in the study eye 7. Any previous or current retinal vascular disease in the study eye 8. Myopia > -6D 9. Clinically significant inflammation or infection within six (6) months prior to study. 10. Use of anticoagulant or antiplatelet therapy other than aspirin and non-steroidal anti-inflammatory agents (NSAID) within 14 days of enrollment 11. Presence of non-healing wound, ulcer, fracture or any medical condition associated with bleeding 12. Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of enrollment 13. History of stroke or myocardial infraction or other high risk patients for cardiovascular or cerebrovascular disease (package insert of Lucentis) 14. Glaucoma or ocular hypertension 15. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) that in the opinion of the investigator could confound the study outcomes or prevent the patient from completing the study 16. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational product. 17. Intolerance or hypersensitivity to topical anesthetics, mydriatics, any of the excipients in Lucentis, fluorescein or components of the drug delivery device 18. A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up 19. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of this study is to determine whether the ForSight Vision 4 drug delivery device used for sustained release of Lucentis can provide clinical measurable benefit over an extended period of time in patients with CNV secondary to AMD and for whom standard treatment with Lucentis is indicated.;Secondary Objective: Specific study objectives have been identified, as follows: Demonstrate that using the V4 sustained release device, a significant reduction of at least 30µm is observed using OCT over a period of 2 months or more.;Primary end point(s): Retinal Thickness on OCT and Visual Acuity | — |
Countries
Austria
Outcome results
None listed