3-year-data of combined navigated laser photocoagulation (Navilas) and intravitreal ranibizumab compared to ranibizumab monotherapy in DME patients

Abstract

PurposeThe prospective, comparative evaluation of combined navigated laser photocoagulation and intravitreal ranibizumab in the treatment of diabetic macular edema has shown advantage of a combination therapy compared to ranibizumab monotherapy at year 1 with significantly reduced injections. The purpose of this retrospective study was to determine the long-term visual gains and need of injections in a 3 year-follow-up period.MethodsRetrospective analysis of patients of the original study in the long-term follow-up from month 12 to 36. BCVA measurements following the original 1 year study were taken using logMAR charts. Injections were provided with standard of care using PRN, based on change in BCVA and CRT using SD-OCT scans. Main outcome measures were change in BCVA and mean number of injections from 12 to 36 months.ResultsBCVA was stable in both groups from 12 through 36 months, showing a change of 0.16 ± 0.1 log MAR. Following the initial reduction in required injections at month 12, combination therapy patients continued to require 1.3 times fewer injections over the next 24 months (2.91 ± 2.3 vs 3.85±3.7 injections for monotherapy).ConclusionsCombination of navigated laser and ranibizumab achieved BCVA gains equivalent to anti-VEGF monotherapy. These results could be maintained through month 36. Required injections were 2.0 injections lower in year 1 and further 1.3 times fewer in year 2 and 3 in the combination group compared to monotherapy. Adding navigated laser photocoagulation to intravitreal anti-VEGF therapy may still represent a superior therapeutic approach to DME patients.

Aflibercept and navigated versus conventional laser in diabetic macular oedema: a 12‐month randomized clinical trial

“…In 3 years of treatment, the study demonstrated a similar improvement in best‐corrected visual acuity (BCVA) but with a lower need for additional intravitreal injections in the combination group (Herold et al. ). However, it is unknown whether the difference in results of combination therapy in DME treatment can be attributed to the choice of photocoagulation system.…”

One-Year Effectiveness Study of Intravitreously Administered Conbercept® Monotherapy in Diabetic Macular Degeneration: A Systematic Review and Meta-Analysis

“…Previously, clinical trials on intravitreal anti-VEGF agent monotherapy in patients with DME showed that the mean improvement in BCVA was 0.81 logMAR after 3 months of treatment [33], and 0.3-3.85 logMAR after 12 months of treatment [34][35][36]. Our analysis of IVC monotherapy showed a mean logMAR BCVA scale improvement in which the largest change (6.09 logMAR) occurred at 3 months after treatment among retrospective studies (n = 4), which was higher than that previously reported.…”

Stellungnahme der DOG, der RG und des BVA zur Therapie des diabetischen Makulaödems

“…Deshalb wurde in aktuellen Studien zum Teil auch Computer-assistiertes navigiertes Lasern verwendet (▶ Abb. 3) [152,254]. Eine genauere Dokumentation und präzise Applikation wird so ermöglicht (OD-OS GmbH, Teltow, Deutschland) [134,255,256].…”

“…Die kombinierte Gabe von 0,3 mg Ranibizumab ("treat and extend" mit OCT-abhängiger Steuerung der Intervalle) mit und ohne navigierte Laserapplikation in Abhängigkeit von der Netzhautdicke wurde mit einem dritten Arm (Ranibizumab mit fixer monatlicher Therapie) verglichen; über 2 Jahre unterschied sich die Anzahl der Ranibizumab-Injektionen in dem Kombinationsarm kaum (17,5 vs. 18,9) gegenüber dem Treat-and-Extend-Monotherapiearm [152]. Eine kleinere Studie mit Wiederbehandlung nach PRN-Schema hat dagegen eine Reduktion der IVOM-Anzahl durch additive Verwendung derselben Lasertechnologie berichtet: Während des ersten Jahres unterschied sich die Behandlungsfrequenz deutlich (0,88 ± 1,23 Kombi-vs. 3,88 ± 2,32 Ranibizumab-0,5-mg-Monotherapie), diese Tendenz setzte sich auch über die folgenden 2 Jahre (2,91 ± 2,3 Kombi-vs. 3,85 ± 3,7 Ranibizumab-0,5-mg-Monotherapie) fort [254].…”