Targeted retinal laser photocoagulation to areas of ischemia in the peripheral retina does not appear to reduce the burden of intravitreal aflibercept injections in patients with diabetic macular edema (DME) compared with intravitreal aflibercept therapy alone, according to a 2-year study published in Eye. Treat-and-extend (T&E) aflibercept therapy, without a loading phase, is safe and effective for treating DME, according to the report.
Between 2016 and 2018, the prospective, double-masked multicenter controlled trial (ClinicalTrials.gov Identifier: NCT02432547) in Australia included 48 eyes from 47 adult patients (mean age, 59.9 years; 31 men, 16 women) with diabetes mellitus. A total of 27 eyes were randomly assigned to combination therapy (aflibercept and targeted retinal laser photocoagulation) and 21 eyes were randomly assigned to aflibercept monotherapy. The aflibercept monotherapy group underwent placebo laser. The main outcome measure was the mean number of intravitreal aflibercept injections in each of the 2 treatment groups at 2 years.
In total, 67% of the combination therapy eyes and 67% of the monotherapy eyes completed the study.
The number of intravitreal treatments given were similar in the combination therapy group (10.5, [SD 5.8]) and the monotherapy group (11.8 [SD 5.6]) (P =.44).
The mean visual improvement was +4.0 (-1.8, 9.8) letters and +7.8 (2.6, 12.9) letters, (P =.32), mean reduction in central macular thickness (CMT) was -154 (-222, -87) µm and -152 (-218, -86) µm, (P =.96), the proportion of eyes with CMT thinner than 300 µm (48% and 67%; P =.50) in both the combination and monotherapy treatment groups, respectively.
Safety outcomes were similar in both groups.
“We found no reduction in the requirement for aflibercept injections in eyes with [diabetic macular edema] and peripheral retinal ischemia when treated with the addition of targeted retinal laser photocoagulation,” according to the researchers. “We also found that T&E aflibercept treatment, without a loading phase, is a safe and effective treatment for DMO, leading to fewer clinic visits and a lower treatment burden.”
Study limitations include its retrospective design, the low study completion rate (67%), and the small sample size.
Disclosure: This research was supported by Bayer. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Cornish EE, Wickremasinghe S, Mehta H, et al. Aflibercept monotherapy versus aflibercept with targeted retinal laser to peripheral retinal ischemia for diabetic macular oedema (LADAMO). Eye. Published online April 17, 2023. doi:10.1038/s41433-023-02525-9