Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Filters applied. Clear all
Randomized Controlled Trial
. 2018 Aug 23;13(8):e0202483.
doi: 10.1371/journal.pone.0202483. eCollection 2018.

3-year-data of Combined Navigated Laser Photocoagulation (Navilas) and Intravitreal Ranibizumab Compared to Ranibizumab Monotherapy in DME Patients

Affiliations
Free PMC article
Randomized Controlled Trial

3-year-data of Combined Navigated Laser Photocoagulation (Navilas) and Intravitreal Ranibizumab Compared to Ranibizumab Monotherapy in DME Patients

Tina Rike Herold et al. PLoS One. .
Free PMC article

Abstract

Purpose: The 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.

Methods: Retrospective 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.

Results: BCVA 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).

Conclusions: Combination 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.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Best corrected visual acuity in log MAR from baseline to 36 months in both groups.
Fig 2
Fig 2. Reduction of central retinal thickness in μm from baseline to 36 months.
Fig 3
Fig 3. Total number of injections from month 1 to 36.
Combination therapy shows a median of 6 injections within 36 month. Monotherapy shows a median of 8 injections within 36 months.
Fig 4
Fig 4. Number of injections in every year of the 36 month follow-up.

Similar articles

See all similar articles

Cited by 2 articles

References

    1. Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XVII. The 14-year incidence and progression of diabetic retinopathy and associated risk factors in type 1 diabetes. Ophthalmology. 1998;105(10):1801–15. 10.1016/S0161-6420(98)91020-X . - DOI - PubMed
    1. Klein R, Knudtson MD, Lee KE, Gangnon R, Klein BE. The Wisconsin Epidemiologic Study of Diabetic Retinopathy XXIII: the twenty-five-year incidence of macular edema in persons with type 1 diabetes. Ophthalmology. 2009;116(3):497–503. 10.1016/j.ophtha.2008.10.016 - DOI - PMC - PubMed
    1. Fong DS, Aiello LP, Ferris FL 3rd, Klein R. Diabetic retinopathy. Diabetes Care. 2004;27(10):2540–53. . - PubMed
    1. Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118(4):615–25. 10.1016/j.ophtha.2011.01.031 . - DOI - PubMed
    1. Nguyen QD, Shah SM, Khwaja AA, Channa R, Hatef E, Do DV, et al. Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology. 2010;117(11):2146–51. 10.1016/j.ophtha.2010.08.016 . - DOI - PubMed

Publication types

Grant support

The authors received no specific funding for this work.
Feedback