Fewer Visits for Aflibercept Injection With Observe and Plan

Damian McNamara

September 11, 2016

COPENHAGEN — An "observe-and-plan" regimen for scheduling aflibercept injections improves visual acuity in patients with neovascular age-related macular degeneration, and could improve the efficiency of clinics treating these patients, a prospective 2-year study suggests.

"The take-home message is that the observe-and-plan regimen in neovascular AMD allows for good visual results with the usual number of injections, yet with a strongly reduced number of visits," said investigator Irmela Mantel, MD, from the University of Lausanne in Switzerland.

The observe part of the regimen relies on a prediction of the need for retreatment. After three loading doses of aflibercept, patients are observed to predict the likely interval for disease recurrence.

This predication assessment is used in the plan part of the regimen to determine the spacing of the next three injections (with an interval from 1 month to 3 months). During clinical assessments, performed at least every 6 months, clinicians determine the effectiveness of the treatment and adjust the plan as needed.

This allows "for better investment of resources or the management of more patients with the same resources," Dr Mantel told Medscape Medical News.

She presented 2-year data for 99 eyes here at the European Society of Retina Specialists 16th EURETINA Congress.

During the first 12 months, the mean number of injections was 8.7 and the mean number of ophthalmic evaluations was 3.8. During the second 12 months, the mean number of injections was 6.5 and the mean number of ophthalmic evaluations was 2.8.

The primary outcome of the study was visual acuity.

Table. Outcomes Over the 24-Month Study Period

Outcome Baseline 3 Months 12 Months 24 Months
Mean visual acuity (EDTRS letters) 61.8 +8.5 +8.0 +6.2
Mean central retinal thickness (µm) 438 –152 –155 –155


In terms of adverse events, two patients experienced a hemorrhage caused by pigment epithelium rupture (one at month 4 and one at month 12) and one patient developed endophthalmitis. There were no severe recurrences of neovascular age-related macular degeneration.

Patient assessments can be the most time-consuming and resource-intensive aspects of caring for these patients. The observe-and-plan strategy can improve the chronic-care management of a larger number of patients, Dr Mantel and her colleagues write in their abstract. "This might ultimately improve real-life visual outcomes in the context of limited resources," they add.

This massively reduces the number of outpatient visits.

Dr Mantel was involved in a previous study that demonstrated similar benefits with an observe-and-plan regimen of ranibizumab used over 2 years to treat patients with neovascular age-related macular degeneration (Eye [Lond]. 2015;29:342-349).

"We use this protocol at our hospital," said session moderator David Steel, MD, from the Sunderland Eye Infirmary in the United Kingdom. "It's kind of a 'halfway house' between treat-and-extend and PRN approaches."

"With plan and observe, you're making decisions at less frequent intervals," he told Medscape Medical News. "For treat and extend, you need to make a double clinical appointment — for patient evaluation and injections. We have nurses who can perform the injections, but they don't do the patient assessments."

With this regimen, "you can organize the next three visits at one time. This massively reduces the number of outpatient visits," he said. Patients like not having to come in for monthly clinical assessments, he pointed out.

It is still not clear whether the plan-and-observe regimen increases the number of injections over the long term, "but you're still doing less than a monthly fixed regimen," said Dr Steel.

Dr Mantel has disclosed no relevant financial relationships. Dr Steel is a member of the Bayer Advisory Board.

European Society of Retina Specialists 16th EURETINA Congress. Presented September 10, 2016.

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