A prospective clinical trial to evaluate the V4 Drug delivery device for long term delivery of Ranibizumab for the Treatment of Choroidal Neovascularization” - Drug Delivery Device for Long Term Delivery of Ranibizumab for the Treatment of Choroidal Neovascula

• Conditions: 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.

• Registration Number: EUCTR2010-023923-78-AT
• Lead Sponsor: Forsight Vision 4, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-27
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <75% of the lesion size representing scar, pigment epithelial detachment, blood or atrophy). 2. Retinal thickness due to edema of at least 300µm in study eye 3. Not eligible for laser treatment 4. Best corrected visual acuity of 20/50 or worse in the eye to be treated 5. Best corrected visual acuity of 20/40 or better in the fellow eye 6. Good visibility of macular area on biomicroscopy 7. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified