| Trial Design |
A prospective, open label, interventional, single centre, investigator led, phase II study to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes. |
| Study Aim |
The aim of this study is to determine if ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with DM and DMO, will have a beneficial effect on improving BCVA, reducing central subfield thickness, increasing central retinal sensitivity and retinal perfusion, increasing tear production and improving quality of life with no adverse events.
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Objective 1: The aim or primary objective of the study is to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus (DM) and DMO will have a beneficial effect on mean change in best corrected visual acuity (BCVA) from baseline values to week 12.
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Objective 2: The secondary objectives are to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus and DMO can improve vision (as determined by the % of participants with a > 10 and > 15 ETDRS letter gain), reduce central subfield thickness, increase central retinal sensitivity, increase tear production and improve retinal perfusion and quality of life with no deleterious side effects. The effects of ARA 290 on the systemic and metabolic control of participants will be also evaluated in an exploratory manner.
ARA 290 antibodies will be determined as, if they were to develop in people undergoing this treatment they could have an impact on the potential subsequent response to it
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