Observe and Plan Strategy Touted for Macular Degeneration

Damian McNamara

September 27, 2013

HAMBURG, Germany — Individualizing a long-term treatment regimen with ranibizumab (Lucentis, Genentech, Novartis) can pay off in terms of fewer injections for patients with age-related macular degeneration, a new study suggests.

The tailored regimen "improves vision as well as other retreatment regimens and, most important, maintains the visual gain over time — comparable to the monthly retreatment regimen that set the gold standard for best visual outcome," said lead investigator Irmela Mantel, MD, from Jules Gonin Ophthalmic Hospital in Lausanne, Switzerland.

Among the benefits of the tailored regimen are fewer antivascular endothelial growth-factor injections for patients and an increased capacity for clinician practices to provide treatment for such patients, Dr. Mantel told Medscape Medical News.

She presented the study results here at the 13th EURETINA Congress. Investigators prospectively assessed an observe and plan strategy in 104 consecutive patients with treatment-naive neovascular age-related macular degeneration.

 
This is an important study. It shows that you can modulate your treatment and reduce the burden of a full waiting room.
 

A tailored approach makes sense because, although the need for retreatment varies substantially within a group of patients, it remains relatively stable for each individual, Dr. Mantel explained.

Each study participant received 3 monthly injections of ranibizumab during the standard loading-dose phase of treatment. Investigators then calculated the interval to disease recurrence for each participant during monthly observation visits. They shortened this interval by 2 weeks and devised a treatment plan for up to 6 months that did not involve intermediate visits.

For example, a patient who experienced disease recurrence 12 weeks after the loading-dose phase would receive 1 injection immediately, followed by a subsequent injection at 10 weeks (12 weeks minus 2 weeks) and another treatment visit at 20 weeks (2 × 10 weeks).

With this follow-up formula, the patient can skip the "many unnecessary visits" involved in a regimen of monthly re-evaluation, Dr. Mantel explained. "The existence of a regular recurrence rhythm allows the prediction of need for retreatment."

There is a caveat to the minimum retreatment period. "In cases of later recurrence — more than 4 months after the last injection — it might sometimes be insufficient to treat only every 3.5 months, and the physician should consider closer retreatment sessions," Dr. Mantel explained.

Table. Observe and Plan Treatment Strategy (n = 115 Eyes)

Treatment Year 1 Year 2
Mean interval (months) 2.08 2.08
Mean number of visits 3.96 2.93

 

We observed "very good improvement" in visual acuity and a high degree of stability, Dr. Mantel reported. The proportion of eyes gaining more than 3 lines was 30% at 2 years, and 83% had no change in the previous 3 months.

The mean number of visits decreased from the first to second year of the study. Dr. Mantel characterized this as "probably the most important outcome."

"We only needed to see patients again 4 times in the first year and about 3 times in the second year, so most patients only had to come back 5 or 6 times after baseline," she explained.

"This is an important study," said session moderator Jean-Jacques De Laey, MD, from the University of Ghent in Belgium. "It shows that you can modulate your treatment and reduce the burden of a full waiting room."

"The intention of the study is very good," said Laurent Kodjikian, MD, from Hopitaux de Lyon in France, who was asked by Medscape Medical News to comment on the findings. "It's a good idea to try to individualize the treatment. It is difficult to optimize follow-up of these patients."

Future research is warranted to validate the findings, and a less complex formula could increase the likelihood of its clinical application, noted Dr. Kodjikian, who is lead author of the GEFAL study, which demonstrated similar improvements in visual outcomes at 1 year with bevacizumab (Avastin, Genentech) and ranibizumab.

Novartis supported this study's manuscript review. Dr. Mantel reports being a consultant for Novartis, Bayer, and Allergan. Dr. De Laey and Dr. Kodjikian have disclosed no relevant financial relationships.

13th EURETINA Congress. Presented September 26, 2013.

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