US-based biopharmaceutical company Clearside Biomedical has begun enrolling patients in its Phase IIb trial of CLS-AX (axitinib injectable suspension).
The multi-centre ODYSSEY trial will evaluate CLS-AX’s efficacy for treating neovascular age-related macular degeneration (wet AMD).
It intends to enrol a total of 60 participants with wet AMD within 36 months of screening.
Of all the participants, 40 will receive CLS-AX while 20 will be given aflibercept for 36 weeks.
Participants having a history of two to four anti-VEGF treatments six months before screening and a history of response to the treatment are eligible to participate in the study.
Participants in both arms will receive three 2mg loading doses of aflibercept a month. At the second loading dose from baseline, participants in the CLS-AX arm will receive one 1mg dose.
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The mean change in best corrected visual acuity from baseline to week 36 is the primary outcome measure while determining other changes in visual function and ocular anatomy such as CST are secondary outcome measures.
Other secondary outcome measures of the trial are the need for supplemental treatment and the treatment burden as measured by total injections over the duration of the trial.
ODYSSEY is an active-controlled, parallel-group, randomised, double-masked trial due to be conducted over 36 weeks.
Clearside president and CEO Dr George Lasezkay said: “CLS-AX will be delivered via our patented SCS Microinjector giving us unprecedented access to the back of the eye to directly target the site of the disease behind the visual field.
“We believe that the number of participants, duration, and outcome measures of the study will provide the necessary clinical data to design a CLS-AX Phase III programme.
“We are targeting a total of 30 US-based clinical trial sites for ODYSSEY and expect to report topline data from the trial in the third quarter of next year.”