Laird Harrison

July 15, 2015

VIENNA — For patients with age-related macular degeneration, results are similar whether aflibercept (Eylea, Regeneron Pharmaceuticals) is administered with a treat-and-extend regimen or a fixed dose, results from the ongoing ATLAS study show.

With the treat-and-extend regimen, patients received a mean of eight injections in the first year of the study, said Francis Char DeCroos, MD, from Southeastern Retina Associates in Chattanooga, Tennessee. This could save patients and their caregivers the discomfort and inconvenience of monthly injections.

And with aflibercept, treat-and-extend "improves both anatomy and vision," he told Medscape Medical News.

Dr DeCroos presented 1-year ATLAS results here at the American Society of Retina Specialists (ASRS) 2015 Annual Meeting.

Trials of vascular endothelial growth factor (VEGF) inhibitors in patients with age-related macular degeneration have typically used fixed monthly doses. But alternatives, and two in particular, have been examined.

With the as-needed approach, clinicians typically give intravitreal injections only when patients show signs of exudative disease activity. However, after 1 year of treatment, outcomes are not as good with as-needed dosing as with fixed doses, Dr DeCroos explained.

Fewer Injections

With treat-and-extend, clinicians give injections monthly injections until signs of exudation have resolved. The interval between visits is then lengthened sequentially, typically by 1 to 2 weeks, as long as there are no signs of recurrent exudation.

Studies with ranibizumab and bevacizumab have suggested that this approach could reduce the number of injections without making the treatment less effective.

Most retina specialists in the United States now use a treat-and-extend regimen, but it is less common in the rest of the world, said Dr DeCroos.

His team conducted the multicenter, prospective, open-label ATLAS study because they could not find any prospective studies of a treat-and-extend aflibercept regimen.

They treated 40 eyes from 40 patients with age-related macular degeneration every 4 weeks until no signs of macular exudation appeared on spectral domain optical coherence tomography. Treatment intervals were then extended by 2 weeks unless a patient lost at least five letters of visual acuity or showed signs of macular fluid, a new macular hemorrhage, or leakage on fluorescein angiography.

The maximum treatment interval was 16 weeks. In most trials of treat-and-extend bevacizumab or ranibizumab regimens, the maximum interval was 12 weeks, Dr DeCroos said.

Table. Per Protocol Analysis at 1-Year Follow-up

Outcome Baseline 1 Year P Value
Best corrected visual acuity, letters 58.1 66.1 <.001
Mean central retinal thickness, μm 351.6 205.0 .002

Of the 40 patients, five discontinued the study regimen. However, results from the intention-to-treat analysis were similar to those from the per protocol analysis, and in the intention-to-treat analysis, there were more patients with a Snellen score of at least 20/40 at 1 year than at baseline (48% vs 18%).

There were three systemic adverse events in the study: one death from any cause, one atherothrombotic event, and one cardiac disorder.

In the per protocol analysis, the mean treatment interval was 6.7 weeks. Saving about four injections a year could make a big difference to a lot of people, said Dr DeCroos.

"It's not just your 80-year-old patient, it's the people who care for them," he added. "If you can help people by getting them a similar result without having to come in so often, it's a perk."

The 2-year results will shed even more light on this approach, he said.

One of Many Protocols

The results come as no surprise, said session moderator Susanne Binder, MD, from the Rudolf Foundation Clinic at the Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery in Vienna.

However, she said she was struck by the variety of protocols for anti-VEGF therapy presented at this meeting, which suggests that the field is far from a consensus on the best approach. "We have not found the right solution," she told Medscape Medical News, pointing out that some patients with age-related macular degeneration are still not benefiting from the therapies.

Factors such as exudation and vitreomacular adhesions do not provide enough information to determine who needs retreatment, she said. "We're missing something. I simply think we need to find other factors."

This study was sponsored by Regeneron Pharmaceuticals. Dr DeCroos has disclosed no relevant financial relationships. Dr Binder reports that she has consulted for Carl Zeiss.

American Society of Retina Specialists (ASRS) 2015 Annual Meeting. Presented July 13, 2015.


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