24-month clinical outcomes of a treat-and-extend regimen with ranibizumab for wet age-related macular degeneration in a real life setting

Abstract

BackgroundTo evaluate the clinical effectiveness and analyze the outcomes of a treat-and-extend (T&E) treatment regimen with ranibizumab for wet age-related macular degeneration (ARMD) in real life clinical settings over the first 2 years (24 months) of treatment.MethodsRetrospective analysis of visual acuity, spectral domain optical coherence tomography (SD-OCT) parameters and treatment burden data of 56 eyes of 54 unselected treatment naive patients diagnosed with exudative ARMD. Monthly injections were offered until no signs of disease activity such as intra-retinal (IRF) or sub-retinal fluid (SRF) were evident on SD-OCT, followed by a gradual extension of the treatment interval by 2 weeks until a maximum of 12 weeks.ResultsThe study met its main objective, demonstrating a mean best-corrected visual acuity gain of 8.3 letters (mean 68.8 ± 11) at month 12 and 5.2 letters (mean 65.7 ± 12.3) at 24 months compared to baseline (mean 60.5 ± 8.9). Anatomical improvement was also documented with a mean reduction of central retinal thickness by 139.7 μm at 24 months (244.9 ± 48.3) compared to baseline (384.6 ± 154.9). Forty-seven eyes (83.9% N = 56) gained vision or preserved baseline vision with 23 eyes (41.1%) gaining 10 letters or more at month 12. Out of the 46 eyes that completed 24 months of treatment and monitoring, 27 (58.7% N = 46) kept a BCVA above baseline with 18 of those (39% N = 46) maintaining a 10-letter gain throughout the 24 months. Six eyes (13% N = 46) lost more than 10 letters by month 24. The mean number of injections was 12.1 ± 2.8 over the 24-month period. Twenty-seven eyes (55.1% N = 56) achieved a treatment interval of 10 weeks or more at month 12, while the respective number at month 24 was 20 eyes (43.4% N = 46) in addition though to four more patients (8.7% N = 46) who were not receiving injections at month 24 since they were placed on a Monitor & Extend regime.ConclusionsThis is the first UK real-life study of a T&E treatment protocol with ranibizumab for exudative ARMD in a 24-month period and suggests that such a regimen is clinically effective and can achieve favourable outcomes with a significant reduction of the treatment burden compared to monthly PRN.

Injections frequency and health care costs in patients treated with aflibercept compared to ranibizumab: new real-life evidence from Switzerland

“…If one of the two drugs would show a clear advantage over the other in terms of risk and treatment burden recommendations and clinical practice guidelines should be adapted accordingly. Currently, two alternative treatment strategies are gaining popularity among retina specialists [ 9 ]. As opposed to fix monthly or bimonthly injection schemes, Pro re nata (PRN) means that injections are carried out as needed.…”

“…As opposed to fix monthly or bimonthly injection schemes, Pro re nata (PRN) means that injections are carried out as needed. The Treat & Extend (T&E) protocol is based on the response to the last injection and decision to reduce or prolong injection intervals is being taken accordingly [ 7 , 9 , 10 ].…”

Initiation and maintenance of a Treat-and-Extend regimen for ranibizumab therapy in wet age-related macular degeneration: recommendations from the UK Retinal Outcomes Group

“…Health professionals may also wish to update their core knowledge on the current status of the published literature on the T&E regimen in nAMD. A detailed review of these publications is beyond the scope of this article but we have provided a convenient summary in Table 1 of the 15 key publications 10 , 11 , 16 , 32 , 34 – 37 , 39 , 41 – 46 in this field. However, it is worth highlighting that a recent systematic review on T&E in nAMD by Rufai et al ana-lyzed the outcomes of 748 eyes from nine studies and found mean VA gain of 8.92 letters with a mean of 8.60 injection at 1 year.…”

“…Since the change of licensed posology to a Treat-and-Extend (T&E) regimen for ranibizumab therapy in 2015 in the UK and 2012 in other countries, 9 there has been an emerging body of evidence reporting better visual outcomes with the T&E approach than with the PRN regimen in a real-world setting. 10 – 14 …”

<p>Providing a Safe and Effective Intravitreal Treatment Service: Strategies for Service Delivery</p>

“…12,[14][15][16][17][18][19][20][21][22] Additionally, there is an emerging body of evidence reporting better visual outcomes with the T&E regimen than PRN in various real-world studies. [23][24][25] In a meta-analysis of over 25,000 patients with nAMD the mean change in VA for patients receiving T&E was +8.8, +6.7, and +5.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at year 1, year 2, and ≥3 years, respectively. In comparison, patients treated with PRN had +3.5, +1.3, and −1.9 ETDRS letters at the same time intervals.…”