Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema (ReCaLL): a single center, randomised, controlled, non-inferiority clinical trial

Abstract

Background To evaluate if a combination therapy with micropulse diode laser (MPL) shows non-inferiority on visual acuity (BCVA) within 12 months in comparison to standard therapy, i.e. intravitreal injection of ranibizumab alone. Setting Institutional. Prospective randomized single-center trial . Methods Patients with diabetic macular edema (DME) received three intravitreal injections of 0.5 mg ranibizumab during the upload phase and were then randomised 1:1 to receive either the same dosage of ranibizumab (0.5 mg) injections pro re nata alone (IVOM-Group; n = 9), or with two additional treatments with micropulse diode laser (IVOM+Laser-Group; n = 10). The primary endpoint was change in BCVA after 12 months. Secondary endpoints were change in central macular thickness and overall number of ranibizumab injections. Results BCVA increased significantly in both groups (IVOM: + 5.86, p < 0.001; IVOM+Laser: + 9.30; p < 0.001) with corresponding decrease in central macular thickness (IVOM: − 105 μm, p < 0.01; IVOM+Laser: − 125 μm; p < 0.01). Patients with additional laser treatment had better visual improvement (group comparison p = 0.075) and needed fewer ranibizumab injections (cumulative proportion of injections 9.68 versus 7.46 in IVOM-Group and IVOM+Laser-Group, respectively). Conclusion Non-inferiority of combination therapy in comparison to standard therapy alone could be demonstrated. Patients with additional laser therapy needed fewer ranibizumab injections. Trial registration Registered 10 February 2014 on ClinicalTrials.gov; NCT02059772 .

Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema

“…There is statistically significant higher rate of decrease in the central macular thickness in diabetic patients with macular edema who received ranibizumab alone than those who received ranibizumab and laser therapy. However, in the study of Furashova et al, 11 CMT decreased significantly in each treatment group over the study course. The effect of the treatment on CMT seems to be more prominent within the upload phase than later on and laser treatment seems not to contribute to this effect.…”

“…However, in the study of Furashova et al, 11 best corrected visual acuity (BCVA) increased statistically significant in both treatment groups till month 12. No significant differences could be found in BCVA change between the two groups at any time.…”

Treatment of Macular Edema in Vascular Retinal Diseases: A 2021 Update

“…Although a lower incidence of complications was reported with SML treatment compared with conventional laser treatment, SML treatment has not shown superior effectiveness [31][32][33][34]. However, the use of a combined treatment may be an effective and safe alternative for ME treatment and may reduce the number of intravitreal anti-VEGF injections required [34,35].…”

“…They concluded that fewer IVB injections were needed when laser treatment was added; however, a significant increase in BCVA was not achieved [34]. Similarly, Furashova et al reported that patients treated with ranibizumab combined with additional laser treatment experienced greater visual improvement and required fewer ranibizumab injections compared with patients treated only with ranibizumab [35].…”

Current Management of Diabetic Macular Edema

“…Some randomized clinical trials have demonstrated that subthreshold grid laser treatment is as effective as conventional focal/grid laser photocoagulation, though slower in terms of resolution of DME, in achieving the same functional and anatomical effects [237,238]. There have been reports of the benefits of combining SDM and intravitreal anti VEGFs in treating DME [239,240].…”