Reducing the clinical burden of ranibizumab treatment for neovascular age-related macular degeneration using an individually planned regimen

Abstract

Aims: The purpose of this study was to clinically validate an individually planned treatment regimen for neovascular age-related macular degeneration (nAMD), termed, observe and plan. This regimen was based on the predictability of an individual's need for retreatment and aimed to reduce the clinical burden, while obtaining good functional results.

Methods: This was a prospective case series that included 104 patients (115 eyes) with treatment-naive nAMD. Following three loading doses of ranibizumab, monthly observation visits allowed the disease recurrence interval to be determined. The recurrence interval was reduced by 2 weeks to give the retreatment interval for the next three injections. Periodical control visits (at least every 6 months) allowed the effectiveness of the treatment to be assessed and individual intervals adjusted.

Results: Mean visual acuity (VA) improved by 8.7 and 9.8 letters in months 3 and 12, respectively. The mean number of injections during the 12-month study was 7.8, while the mean number of ophthalmic examinations between months 3 and 12 was 3.97. The mean treatment interval after the loading doses was 1.97 months.

Conclusions: The observe-and-plan regimen significantly improved VA. This was obtained with fewer clinic visits compared with other regimens, which could ease the burden of nAMD treatment.

Trial registration number: Commission cantonale (VD) d'éthique de la recherché Clinique, Université de Lausanne, Protocole 351/11.

Figure 1

Treatment algorithm of this observe-and-plan regimen with ranibizumab for neovascular age-related macular degeneration. Every patient received the initial loading dose of 3 ranibizumab injections at 1-month intervals, (abbreviated as 3×1). Subsequently, findings on optical coherence tomography defined the pathway in the algorithm; 3×1*=three injections at fixed interval of 1 month and assessment visit 1 month after the third injection (total assessment interval 3 months); 3×1.5*=three injections at fixed interval of 1.5 months and assessment visit 1.5 months after the third injection (total assessment interval 4.5 months); 3×2*=three injections at fixed interval of 2 months and assessment visit 2 months after the third injection (total assessment interval 6 months); 2×2.5*=two injections at fixed interval of 2.5 months and assessment visit 2.5 months after the third injection (total assessment interval 5 months); 2×3*=two injections at fixed interval of 3 months and assessment visit 3 months after the third injection (total assessment interval 5 months). ^#The possible treatment intervals for the fixed injection plan ranged from a minimum of 1 month to a maximum of 3 months. In case of an injection—recurrence interval more than 3 months—the patient received the treatment plan of two injections every 3 months (2×3 months). ^†Empty arrow=decision in case of exudative signs on ophthalmic examination, full arrow=decision in case of dry macula on ophthalmic examination.

Figure 2

Mean change of best corrected visual acuity (BCVA; upper graph) and of central retinal thickness (CRT) measured using optical coherence tomography (lower graph) of all study eyes treated with ranibizumab for neovascular age-related macular degeneration following an observe and plan regimen during the 12 month study period. Error bars represent SE of the mean.

Figure 3

Distribution of the number of clinic visits with ophthalmic examination between months 3 and 12.