Lucentis sets new high standard for treatment of neovascular AMD

I mentioned in the last blog that Lucentis® has set a new high standard for the treatment of neovascular AMD. To match the results with Lucentis, any new treatment should be as good as or better than the following results:

1. 95% of patients should not lose 15 or more letters of vision at one year.
2. 90% of patients should not lose 15 or more letters at two years
3. The entire group of treated AMD patients should gain 6.6 letters or just over one line of vision at two-years of follow-up
4. A third of the treated patients should gain 15 or more letters, (three lines), of vision at one year.
5. 40% of treated patients should be 20/40 or better.

The downsides to Lucentis are:

1. It has to be injected into the eye once a month.
2. After it’s stopped, the leakage, edema, and vision loss often return.
3. Although it stops choroidal neovascularization from growing it usually doesn’t destroy it permanently.
4. It’s expensive.

Genentech sponsored the PIER study to see if fewer injections of Lucentis would work as well as monthly injections. Patients initially received three monthly doses of Lucentis followed by injections only every three months for one year. The patients didn’t do quite as well as those who got monthly injections:

1. 90% of patients didn’t lose 15 letters at one year.
2. The entire group had about the same vision at one year that they started with instead of a gain of 6.6 letters.
3. 13% gained fifteen or more letters of vision.
4. 30% were 20/40 or better.

Retinal doctors felt that they could improve these results if they followed patients carefully and re-injected Lucentis on an “as needed” basis. Phil Rosenfield from Miami reported on a study in which patients received three monthly injections and then were followed every month thereafter. They received another injection if fluid recurred on the OCT, the vision decreased, or if there was a new hemorrhage or area of neovascularization. This treatment plan appeared to work as well as giving injections every month for a year and has the benefit of the patient often needing fewer injections.

Another strategy to reduce the number of injections needed to control the neovascularization is to use a combination of Avastin® or Lucentis® followed by PDT. PDT can close neovascularization permanently but it can also cause damage to the normal vessels in the choroid, later regrowth of neovascularization, and vision loss. PDT alone is not as good as Avastin or Lucentis alone. But now retinal doctors are trying a combination treatment, Avastin or Lucentis followed 1-2 weeks later by low dose PDT. Usually the light dose used in the PDT is one-half or even less of the normal dose. It’s hoped that this lower light dose will limit the damage caused by PDT. The goal is to close the abnormal blood vessels permanently but get the same visual results as with Avastin or Lucentis alone.

There were four papers reporting on this combination treatment. The combination treatment did reduce the number of injections. The visual results were close to but not quite as good as with Avastin or Lucentis alone. This treatment could be considered in patients who have recurrent fluid despite numerous injections. Retinal doctors are working hard to get the right recipe of Avastin or Lucentis with PDT and maybe even intraocular Kenalog. The right recipe may have the same visual result as Avastin or Lucentis alone but require fewer treatments and result in permanent closure of the abnormal blood vessels.