Phase 2b wet AMD clinical trial

Opthea has completed enrolment of 366 treatment-naïve patients into a randomised, controlled Phase 2b clinical trial investigating OPT-302 administered in combination with the VEGF-A inhibitor ranibizumab (Lucentis®) compared to ranibizumab alone

Phase 2b wet AMD clinical trial (ongoing)

Opthea’s Phase 2b wet AMD clinical trial is a randomized, double-masked, controlled study investigating OPT-302 + ranibizumab (Lucentis®) compared to ranibizumab alone in 366 wet AMD patients. This trial is fully recruited and the company is now focussed on the completion of dosing in all patients and various trial close-out activities.

Opthea will report outcomes from the trial in the fourth quarter of calendar year 2019.

Opthea enrolled 366 patients into the Phase 2b trial at sites in the US, Europe (United Kingdom, France, Poland, Hungary, Spain, Latvia, Italy and Czech Republic) and Israel.

Patients are randomised in 1:1:1 ratio to each of three treatment groups to investigate the clinical efficacy and safety of two doses of OPT-302 (0.5 mg and 2.0 mg) each in combination with ranibizumab (0.5 mg) compared to ranibizumab (0.5 mg) + sham injection. Treatments are administered on a monthly basis for 6 months via sequential intravitreal (ocular) injection.

The Phase 2b trial is being conducted in patients who have not received any therapy for their newly diagnosed wet AMD (treatment-naïve patients). The primary endpoint of the study is the mean change in best corrected visual acuity (BCVA) from baseline to week 24. A number of secondary endpoints will also be evaluated, including investigation of OPT-302 on anatomical parameters of the wet AMD lesion using imaging techniques such as optical coherence tomography and fluorescein angiography.

The Phase 2b trial is fully enrolled and not recruiting any more patients.

More information can be found on the ClinicalTrials.gov website (NCT #03345082)

OPT-302 Phase 2b Trial in wet AMD (n=366)

Phase 2b trial Wet AMD

Primary Objective

  • Mean change from baseline in BCVA (visual acuity) (ETDRS) at week 24

Secondary Objectives

  • The proportion of patients gaining ≥15 or more ETDRS letters from baseline at week 24
  • Area under the BCVA over time curve
  • The proportion of patients losing ≥15 or more ETDRS letters from baseline at week 24
  • Change in central subfield thickness (CST) from baseline at week 24 (SD-OCT)
  • Change in intra-retinal fluid and sub-retinal fluid from baseline to week 24 (SD-OCT)
  • Safety and tolerability

Primary data analysis: est. 4Q CY 2019

Opthea enrolled patients at sites in the US, Europe (United Kingdom, France, Poland, Hungary, Spain, Latvia, Italy and Czech Republic) and Israel.

Phase 1/2a wet AMD study

Opthea has reported encouraging results from a Phase 1/2a study in wet AMD patients.

Data from Opthea’s Phase 1/2a trial in wet AMD patients indicated that OPT-302 is well tolerated when administered as a monotherapy and in combination with ranibizumab (Lucentis®) and suggested that combined administration of OPT-302 + ranibizumab may lead to improved clinical outcomes over ranibizumab alone.

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 advance 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.

OPT-302 Phase 1/2a First-in-Human Study in Neovascular AMD (n=51)

OPT-302 Phase 1-2a First in Human Study in Neovascular AMD