gms | German Medical Science

Purpose: To evaluate if a standardized combination therapy regimen, utilizing 3 monthly ranibizumab injections followed by navigated laser photocoagulation, reduces the number of total ranibizumab injections required for treatment of diabetic macular edema (DME) through the second year.

Design and Methods: Two-year extension study of the CAVNAV study: Twenty-four patients out of 34 patients previously treated with combination therapy for 12 months were followed for an additional one-year period (average total of 27.7 months). All patients had initially received 3 monthly ranibizumab injections (loading phase) followed by navigated laser photocoagulation and additional injections pro re nata (PRN). Main outcome measures were mean number of injections in year 2 and change in BCVA from baseline to last follow-up.

Results: Navigated laser combination therapy improved mean BCVA letter score by 9.5±4.7 letters and reduced central retinal thickness by 162±171 µm (after 12 months: 9 letters and 146 µm, respectively). On average 2.1±1.5 injections were given to maintain visual gains through the second year (after 12 months: 4.1 total, 1.1 after loading phase).

Conclusion: Navigated laser combination therapy demonstrated significant visual gains of more than 9 letters on average that could be maintained through the second year with an average of 2.1 injections. The pivotal RESTORE study had reported year 2 values of 3.8 injections for both ranibizumab monotherapy and conventional laser combination therapy patients with visual gains of 7.9 and 6.7 letters, respectively, indicating that the addition specifically of navigated laser photocoagulation may help reduce injection burden.