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Fewer visits needed with combined suprachoroidal triamcinolone, aflibercept for DME

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Michael S. Ip

CHICAGO — Patients with diabetic macular edema treated with suprachoroidal triamcinolone in combination with aflibercept achieved similar vision in fewer treatment visits compared with patients treated with aflibercept monotherapy, according to a speaker here.

“A combination of aflibercept and suprachoroidal triamcinolone vs. aflibercept monotherapy at week 24 showed similar vision changes, improved OCT central subfield thickness changes in the combination group and similar retinopathy score changes,” Michael S. Ip, MD, said at the American Society of Retina Specialists annual meeting.

The 24-week phase 2 TYBEE trial included 71 treatment-naive patients with DME randomly assigned to receive either combined suprachoroidal CLS-TA (corticosteroid triamcinolone acetonide, Clearside Biomedical) and intravitreal Eylea (aflibercept, Regeneron) or aflibercept monotherapy.

At 24-week follow-up, 36 patients in the combined cohort improved 12.3 letters from baseline compared with 13.5 letters in the 35 patients in the monotherapy cohort, which was not a statistically significant difference, Ip said.

The combination cohort experienced a greater central subfield thickness reduction of 226.5 µm at week 24 compared with 176.1 µm in the monotherapy cohort (P = .035), Ip said.

The combination cohort required 2.8 treatment visits over the 24-week period compared with 4.7 treatment visits for the monotherapy cohort, he said.

Ip and colleagues performed area and maximum extent measurements of the disorganization of retinal inner layers (DRIL) in each cohort. The researchers defined DRIL as one or more of the following boundaries as not separately identifiable: the ganglion cell layer and inner plexiform layer complex, the inner plexiform layer complex and inner nuclear layer, and the inner nuclear layer and outer plexiform layer.

At 24 weeks, the combination cohort experienced 2.2 mm² reduction in area of DRIL compared with 3.6 mm² in the monotherapy cohort, Ip said.

“We feel that DRIL is a biomarker that should be evaluated in future DME clinical trials,” he said. – by Robert Linnehan

Reference:

Ip MS. Suprachoroidal CLS-TA plus aflibercept compared with aflibercept monotherapy for diabetic macular edema (DME): results of a phase 2 trial. Presented at: American Society of Retina Specialists annual meeting; July 27-30, 2019; Chicago.

Disclosure: Ip reports he is a consultant for Boehringer Ingelheim, ThromboGenics, Genentech, Astellas, Allergan, Novartis, Alimera and Allegro.