Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema
Status:
Withdrawn
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
Summary
COLLIDE is a multi-center, open-label, 1:1 randomized study looking at the effects of
aflibercept (AFL; 2.0mg) plus OZURDEX (DEX; 0.7mg) implant combination therapy versus DEX
monotherapy in phakic or pseudophakic eyes with center-involved DME that have demonstrated
prior incomplete response to 3-6 anti-VEGF treatment in 3-9 months. The primary outcome will
be 24 week central subfield thickness. Secondary outcomes include the change in ETDRS BCVA
letters, number of re-injections and re-injection interval, proportion of eyes with 15- and
10- ETDRS letter gained/lost, proportion of eyes with PDR as per Optos color and FA at the
study completion (24+/- 2 weeks) and OCT and OCT angiography biomarkers.
Phase:
Phase 2
Details
Lead Sponsor:
Pradeepa Yoganathan
Collaborators:
St. Michael's Hospital, Toronto Unity Health Toronto