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.
Highlights
Around 29% of patients with diabetes mellitus (DM) age 20 years or older will develop a diabetic macular edema (DME), and according to the WHO, DME is the leading cause of vision impairment in the working class. [1,2,3] Due to the success of antibody-derived inhibitors of vascular endothelial growth factor (VEGF), the management of DME has shifted to intravitreal injection therapy and has mostly replaced Macular Laser Therapy (MLT) as a first-line treatment.[4,5,6,7]
Conventional MLT monotherapy has been largely replaced by intravitreal injection therapy and several studies tried to evaluate the effect of laser treatment in combination with intravitreal injection therapy
We and others have recently shown that the combination of intravitreal ranibizumab and navigated laser treatment in DME requires fewer injections over the course of the disease as compared to intravitreal anti-VEGF injection alone. [16]
Summary
Around 29% of patients with diabetes mellitus (DM) age 20 years or older will develop a diabetic macular edema (DME), and according to the WHO, DME is the leading cause of vision impairment in the working class. [1,2,3] Due to the success of antibody-derived inhibitors of vascular endothelial growth factor (VEGF), the management of DME has shifted to intravitreal injection therapy and has mostly replaced Macular Laser Therapy (MLT) as a first-line treatment.[4,5,6,7]Pivotal anti-VEGF trials demonstrated a stabilisation of the disease in terms of reducing the central retinal thickness (CRT) using injection therapy, they proved its safety and its ability to even improve patientsvisual acuity.[8]To achieve these results adherence to a stringent regimen of frequent intravitreal injections—between seven and twelve in the first year—is required. [9,10,11,12]From several real-life observations, we know that large numbers of intravitreal injections represent a high treatment burden for patients. Pivotal anti-VEGF trials demonstrated a stabilisation of the disease in terms of reducing the central retinal thickness (CRT) using injection therapy, they proved its safety and its ability to even improve patientsvisual acuity.[8]. To achieve these results adherence to a stringent regimen of frequent intravitreal injections—between seven and twelve in the first year—is required. Our own previous data on combining anti-VEGF therapy and MLT performed with the navigated laser (Navilas Laser System, OD-OS GmbH, Teltow, Germany) providing digital planning, image guidance and higher accuracy in laser spot application [17], demonstrated a significant reduction of anti-VEGF injections in the first year with in-trend better visual outcomes than ranibizumab monotherapy. Almost half of the diabetic patients would appreciate a reduction in the number of injections required to achieve the same objective outcomes in terms of visual acuity. [12] for doctors and health care providers in an everyday clinical setting, treating every diabetic eye with intravitreal injections at the right time represents a substantial organisational challenge. [13, 14].
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