After loading dose, monitor and adjust anti-VEGF injection schedule to patient needs

The number of injections can be reduced when patient is monitored closely and placed on a more flexible as-needed regimen.

Ranibizumab is a significant step forward in the treatment of age-related macular degeneration, with the potential to improve vision by three or more lines in 30% to 40% of cases and to stabilize it in 70% of cases.

Based on the conclusions of clinical trials and his own experience, a specialist gave pearls on how to make the best of anti-VEGF treatment with Lucentis (ranibizumab, Genentech/Novartis) in everyday clinical practice.

“Study data suggest that best results are obtained with one injection a month for 2 years. However, provided that the patient is monitored at least once a month, a more flexible regimen can be adopted,” Paolo Lanzetta, MD, a professor at Udine University, said in an interview with Ocular Surgery News.

Decision-making process

A loading dose of three monthly injections can be followed by an as-needed dosing schedule.

Paolo Lanzetta

As-needed re-treatment criteria are currently under evaluation.

“Spectral-domain [optical coherence tomography] is likely to play a central role at all stages of our decision-making process. This new technology allows us to evaluate not only retinal thickness, but also the quality and quantity of intraretinal and subretinal fluids, meaning treatment can be introduced at earlier stages and repeated promptly, before vision is affected,” Dr. Lanzetta said.

The quantification of OCT parameters such as retinal fluid volume will provide surgeons with new and more precise re-treatment criteria, he said.

Current criteria are vision loss of one line or more and an increase in retinal thickness of more than 100 ìm, but there is a trend toward re-treating earlier, when the increase is 50 ìm, with or without vision loss.

“There is no reason why vision loss should not be prevented rather than treated. Constant monitoring is, of course, essential in this respect,” he said.

Response to treatment

A subgroup analysis of the patients treated within the studies of ranibizumab shows that the response to the treatment is individual. There are patients who immediately improve and maintain the improvement, patients who initially improve and then get worse, and patients who do not improve at all.

“If the patient qualifies for the treatment, keep going, and don’t give up when results are disappointing. Bear in mind that whatever happens during the treatment is better than the natural course of the disease. It is also good to know that about 30% of the patients who experience a moderate vision loss, up to three lines, after the first three injections often start getting better at 1 year if treated monthly, according to the MARINA and ANCHOR studies,” Dr. Lanzetta said.

The most critical time during treatment is between month 3 and month 5, he noted. Within this interval, timely monitoring is extremely important, and a higher frequency of re-treatment might be needed.

There is, however, a minority of cases in which the treatment should not be given or should be discontinued.

Patients presenting with a non-active lesion with extensive atrophy of the retinal pigment epithelium and neuroretina without subretinal fluid should not be treated. Those who do not respond to the treatment and retain extensive intra- and subretinal fluid may switch to triple treatment with photodynamic therapy, intravitreal ranibizumab and juxtascleral steroid injection. Finally, the treatment should be discontinued in patients who show progressive RPE and choriocapillary atrophy during follow-up.

Dr. Lanzetta said that, on average, the as-needed regimen allows for a significant reduction in the number of injections per year.

“Four to five instead of 12 is the average in [as-needed] regimen studies,” he said. “Results, provided that individual patients are constantly monitored and promptly treated when needed, can be almost as good, with fewer side effects, a lower risk of complications and a considerable reduction of costs.” – by Michela Cimberle

• Paolo Lanzetta, MD, can reached at University of Udine, Department of Ophthalmology, Piazzale S. Maria della Misericordia, 33100 Udine, Italy; +39-0432-559-905; fax: +39-0432-559-904; e-mail: paolo.lanzetta@uniud.it. Dr. Lanzetta receives funds as a member of the Novartis scientific advisory board.