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Biotech / Medical : PSDV - pSivida Limited
PSDV 1.220+14.0%Mar 29 5:00 PM EST

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From: John McCarthy10/6/2009 1:19:50 AM
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Reducing Treatments an Important Finding for Patients With Age-Related Macular Degeneration: Presented at RC2009
By Cameron Johnston

NEW YORK -- October 5, 2009 -- Adding the intravitreal steroid triamcinolone to monotherapy bevacizumab, or to a combination therapy consisting of bevacizumab plus low-dose photodynamic therapy (rPDT)

does not provide any added benefit in visual outcomes for patients with age-related macular degeneration.

However, the number of treatments required by these patients may differ considerably over the course of a year, and this could come as a welcome advantage in favour of using combination therapies, researchers reported here on October 1 at the Retina Congress (RC) 2009.

The prospective, randomised controlled study involved 103 patients with any lesion type of choroidal neovascularisation secondary to AMD who were treated with either bevacizumab alone (group A; n = 35), bevacizumab plus rPDT (group B; n = 33), or bevacizumab plus rPDT and triamcinolone 2 mg (group C; n = 35).

Patients in group A were treated with bevacizumab 1.25 mg in 3 loading doses given a month apart, followed by PRN (as needed) redosing. In group B, rPDT and bevacizumab were given together on the first day, and then monthly thereafter, if indicated. In group C, triamcinolone 2 mg was given along with bevacizumab and rPDT on the first day, and monthly thereafter, if indicated.

Re-treatments were given when optical coherence tomography showed an increase in retinal thickness of 50 microns over the best previous measurement recorded, or when there were signs of subretinal fluid, or cystoid macular oedema.

The analysis showed that at 1-year follow-up, the mean change in visual acuity was not substantially different between groups (+2.1, +1.5, and +1.6 letters for groups A, B, and C, respectively). More patients receiving double (18%) and triple therapy (17%) were able to get by on just 1 treatment compared with patients receiving monotherapy (3%).

Similarly, an improvement of at least 15 letters in visual acuity was seen in 27%, 24%, and 20% of patients in groups A, B, and C, respectively.

Two findings that were statistically and clinically significant were the length of time between treatments, and the number of treatments given overall. Patients who received bevacizumab plus rPDT (group B) received a mean of 3.39 injections and went for a mean of 102 days between treatments. By comparison, patients receiving triple therapy (group C) had a mean of 3.18 treatments but only went 97 days between treatments. Patients receiving bevacizumab monotherapy (group A) had a mean of 4.57 injections, but went 75 days between treatments.

According to Dr. Tom Sheidow MD, Schulich School of Medicine and Dentistry, University of Western Ontario, and the Ivey Eye Institute, London, Ontario, the differences in visual outcomes were not clinically important, but the fact that some patients may get by with fewer treatments is.

"If you're in the middle of a big city and patients can get to your office easily, then I would say to use only monotherapy, because it's not hard for the patients to come to you for monthly treatments," he said. "But if you are in a rural area, and there is snow for one-third of the year, and the patients are driving 2 and 3 hours to get to your clinic, then anything you can do make sure they need fewer visits will be important to them. It's a quality-of-life issue. A difference of 1 or 2 letters in visual acuity is not important to these patients, but making it easier for them to get to their treatments is."

Funding for this study was provided by QLT Inc.

The 2009 Retina Congress is a combined meeting of the American Society of Retina Specialists, the Macula Society, and the Retina Society.

[Presentation title: Visual Acuity Response Profiles of Patients With Choroidal Neovascular AMD Treated With Quarterly Dosing of Ranibizumab in the EXCITE Study]

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