EVADE Study Evaluates Treat and Extend Use for IAI for DME

Dilsher Dhoot, MD

Clinical trials are an important source of data for physicians treating patients on the ground, but it is also important to conduct studies assessing real-world data.

Previous phase 3 trials have demonstrated the benefits of using fixed dosing in treating diabetic macular edema (DME) patients with anti-VEGF agents, but there are limited studies that have evaluated treat and extend outcomes.

The EVADE study is the first prospective trial assessing treat and extend use for intravitreal aflibercept in DME patients.

“We know that patients do very well on the fixed dosing, we’ve seen that in several trials, but in the real world, data does not mirror these clinical trials and the patients are under dose,” Disher Dhoot, MD, lead author of the study told MD Magazine®. “…The goal of this study was to look at patients with diabetic macular edema to see if treat and extend was a viable option with aflibercept.”

Dr. Dhoot and the investigators set out to assess the treat and extend dosing regimen in comparison with a fixed interval bi-monthly doing regimen following 3 initial monthly injections for subjects with DME receiving for intravitreal aflibercept injections.

The study enrolled 50 patients with DME who were randomized on a 1 to 1 ratio into the fixed dosing group or the treat and extend group.

The fixed interval treatment group received 5 injections from baseline to 16 weeks before converting to 8-week treatment intervals.

The treat and extend group was treated monthly until SD-OCT CRT improved to <350 µm and were then switched to a protocol-defined treat and extend algorithm.

“It’s really hard to standardize treat and extend because everyone has nuances and variances of how they do it,” Dr. Dhoot explained to MD Magazine®. “We tried to standardize it in a fashion in which patients who were doing well were extended and patients who were doing really well were maintained and patients who were not doing great were retained or reduced in their treatment interval.”

According to the results of the first year of the study, in the fixed interval group, the mean best-corrected visual acuity improved from 57 to 64, compared to 61 to 74 in the treat and extend group (P= 0.002, p<0.001).

The authors indicate that the mean CRT improved from 484 to 315 mm (-169 +147 mm) in the fixed interval arm and from 516 to 302 mm (-214+81 mm) in the treat and extend arm both (both p<0.001).”

Patients in the treat and extend arm experienced more physician visits (10.1 vs 8.8, p=0.02) and more injections (9.9 vs 8.8) than the fixed interval arm.

Following the first year of study, visual acuity was higher in the treat and extend arm which also had an increased number of injections and visits.

Despite the similarity in anatomic outcomes in both treatment groups at 1 year, the authors write that “increased frequency of treatment when fluid recurred in the TE arm was associated with better visual outcomes than in the FI q8 week arm of this study.”

The data from the one year outcomes of the EVADE was presented in a poster presentation at the American Academy of Ophthalmology Annual Meeting 2018 in Chicago, Illinois.

Disclosures:

Dilsher S Dhoot MD: Alimera Sciences, Inc.: C,L; Allergan: C; GENENTECH: S,L,C; Regeneron: L,S; Santen, Inc.: C;