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L. Bertazzi, C. Eandi, C. Veronese, G. Staurenghi; A Randomized Registry Trial Utilizing the OPTTX® System for the Diagnosis, Evaluation and/or Tratment of Choroidal Neovascularization (CNV) Feeder Vessel in Wet Age-Related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2009;50(13):1910.
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To describe Registry-02 Study, a 12 months prospective, randomized registered trial enrolling subjects with neovascular AMD for feeder vessels' diagnosis and treatment.
100 subjects with CNV secondary to AMD will be screened with High-Speed Indocianine Green Angiography (HS-ICGA) using the OPTTX® System. A minimum of 40 subjects who have at least one-well defined CNV-FV will be randomized into 1 of 2 treatment arms. 20 subjects will receive only intravitreal anti-VEGF injections on a routine, standard of care basis. The other 20 subjects will receive Choroidal Vessel Closure (CVC) using the OPTTX®-System + intravitreal anti-VEGF injections as needed. Both subjects groups will return for monthly assessment visits up to 12 months post enrollment.At each trial visit the status of the subject's FV closure and CNV status will be evaluated with HS-ICGA, Sodium Fluorescein Angiography (SFA), OCT and BCVA.After baseline treatment subjects will be evaluated and treated as follows:• subjects in the intravitreal anti-VEGF arm will be retreated if there is an increase in central retinal thickness > 100 µm by OCT and or VA is deteriorating (≥ 5 letters on ETDRS chart);• subjects in the CVC + intravitreal anti-VEGF arm will receive CVC with the OPTTX® System if a FV is visible, and intravitreal VEGF if there is an increase in central retinal thickness > 100 µm by OCT and or VA is deteriorating regardless of FV presence.Stable CNV is meant when there is: no new onset of neovascularization, no new macular hemorrage, no increase in exudation by SFA or OCT.
Primary endpoint is to evaluate the effectiveness of the OPTTX® System + administration of intravitreal anti-VEGF or Intravitreal Anti-VEGF alone by monitoring: delay in first retreatment of intravitreal injection, change in VA, frequency of intravitreal injection over the course of 12 months. Secondary objectives will be to evaluate the ocular safety of the OPTTX® System and/or Intravitreal Anti-VEGF by ophthalmological examination and color fundus photographs.
Previous studies suggest that FV treatment is safe and reproducible and can be used as an alternative to the anti-VEGF drugs. Moreover intravitreal anti-VEGF drugs are known to improve AMD lesions and visual outcomes, but a more comprehensive assessment of their action, administration scheduling and safety is needed. The primary objective of this trial is to describe the effects of the OPTTX® System in a combination therapy regime in an AMD subject population, to the intent to delay and reduce the number of intravitreal anti-VEGF injection.
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