PURPOSE:

To describe the results of a clinical trial that uses a unique system for Feeder Vessel Therapy (FVT) for the treatment of age related macula degeneration. This system combines the functions of 2 devices traditionally required to deliver conventional FVT, an imaging-system and a laser treatment device.

METHODS:

A fundus camera has been modified for indocyanine green (ICG) angiography with an 810 nm wavelength diode laser beam. ICG is administered at the time of treatment to allow real-time visualization of feeder vessels. Live ICG images are acquired by a Charged-coupled device camera and displayed on a monitor. The fiber optic of the 810 nm laser photocoagulator is mounted on a joystick-controlled micromanipulator in the camera’s optical system for precisely positioning the laser beam on the fundus while viewing live ICG video images of the choroidal vasculature.

SETTING:

A trial is on-going in Brescia, Italy in which 40 patients have been randomized to either ICG-FVT or FVT alone.

RESULTS:

To date, 24 patients have completed the study,12 of those received the protocol specified treatment regimen. Of the 12 (8 FVT-ICG/ 4 Control FVT), 10 patients have stable or improved vision, as determined by best corrected visual acuity (83%) during the treatment regimen. Fifteen (15) of the 38 treated patients (39%) received photodynamic therapy (11 FVT vs. 4 FVT-ICG).

The total laser energy required to achieve the closure with ICG-FVT group was less than FVT group. In the ICG-FVT treatment group, dye remained in the vessels after their closure, immediately confirming the effectiveness of the treatment.

CONCLUSIONS:

The device enables effective visualization of FV throughout the procedure, high-speed image capture, and improved patient outcomes by stopping the progression of the CNV growth. ICG-FVT appears to be a more effective approach to CNV therapy and increases FV closure with a reduction of concomitant retinal tissue damage.