Phase 1/2a wet AMD clinical trial (completed)
Opthea has reported encouraging results from a Phase 1/2a study in wet AMD patients.
Opthea’s Phase 1/2a clinical trial of OPT-302 in 51 patients with wet AMD was conducted under an FDA approved IND at 14 clinical sites in the USA.
The trial investigated OPT-302 administered alone (as ‘monotherapy’) or in combination with ranibizumab (Lucentis®) administered on a monthly basis for three months.
The primary endpoint of the study was the assessment of the safety of OPT-302 administered via ocular (intravitreal) injection as a monotherapy and in combination with ranibizumab. Secondary endpoints of the trial included preliminary measures of clinical activity, including evaluation of visual acuity using eye charts as well as changes in wet AMD lesions, such as measurement of fluid and thickness of the tissue at the back of the eye, using advanced imaging techniques such as SD-OCT.
Of the 51 patients enrolled, 25 were newly diagnosed, treatment-naïve patients and 26 had received prior intravitreal anti-VEGF-A therapy. The majority of lesion types (72.5%) were occult, 23.5% were minimally classic and 4.0% were predominantly classic.
OPT-302 demonstrated a favourable safety profile in this study as a monotherapy and in combination with ranibizumab treatment. No dose-limiting toxicities (DLTs) were observed and the maximum tolerated dose (MTD) was not reached.
In participants who received combination OPT-302 (any dose) with ranibizumab, the change from baseline in mean best corrected visual acuity (BCVA) at 12 weeks was +10.8 in treatment-naïve patients (n=18) and +4.9 letters in prior treated participants (n=19). The mean change from baseline in central subfield thickness (CST) at 12 weeks decreased in both patient groups by -119 μM and -54 μM respectively.
In patients receiving OPT-302 monotherapy (2.0 mg), 7/13 (54%) did not require anti-VEGF-A rescue therapy throughout the dosing period up to week 12, and the mean change from baseline at 12 weeks in mean BCVA was +5.6 letters (range 0 to 18) and mean CST was -15 μM.
Further details on the Phase 1/2a trial can be found at www.clinicaltrials.gov, Clinical trial identifier: NCT02543229.
Data read outs / Milestones
Opthea will report outcomes from the Phase 2b wet AMD trial in the fourth quarter of calendar year 2019; and anticipates reporting outcomes from the Phase 2a DME trial before the end of calendar year 2019, subject to patient recruitment.