New Studies on AMD: DENALI

We’ve discussed before that the drawback of Avastin or Lucentis is that they don’t permanently close the new blood vessels beneath the retina. Most clinicians give three injections of Avastin or Lucenits at monthly or every six week intervals. They then watch the patients and give additional injections on an “as needed” basis. “As needed” means the patient develops visual loss, new hemorrhage, or most commonly new fluid seen on OCT and therefore needs another injection. Phil Rosenfeld of Miami treated patients using this scheme and found that, on average, patients needed about six injections over the first year of treatment. Some patients however, need injections every month. Patients get tired of these injections and each on of them has a small risk of endophthalmitis. Therefore a treatment for AMD that involves fewer injections is needed.

Novartis is sponsoring the DENALI study which will start soon. In DENALI, patients will be randomized to Visudyne at full or half light doses along with Lucentis or to Lucentis alone. The hope is that the patients who receive Visudyne along with Lucentis will have similar visual results as the patients who receive Lucentis alone but will need fewer injections to control the neovascularization. I think patients would like this, namely to have Visudyne and then maybe two or three injections of Lucentis, and then be done. “Done” means that they would have long term control of the neovascularization with good vision.

We won’t know the results of the DENALI study for over a year but they will be important.

~ Jim Folk, MD