Phase 1b/2a DME Trial

Opthea is investigating OPT-302 administered in combination with anti-VEGF-A therapy in a Phase 1b/2a study for the treatment of persistent/refractory central-involved diabetic macular edema (DME)

Phase 1b DME Dose-Escalation Study (Completed)

Opthea’s Phase 1b dose escalation study enrolled a total of 9 patients, consisting of 3 patients into three treatment cohorts of OPT-302 (0.3, 1 mg and 2 mg) each administered in combination with aflibercept (Eylea®) (2 mg) on a monthly basis for 3 months.

Opthea has reported positive three-month data from the 9 patients. Vision improvement and reductions in retinal swelling were observed following conversion to OPT-302 combination treatment in these patients with persistent DME, with a clear dose-response relationship of gains in visual acuity with ascending OPT-302 dose levels.

Phase 2a DME Trial (Ongoing)

Opthea’s Phase 2a randomized, controlled clinical study with OPT-302 is currently enrolling patients in Australia, the US, Latvia and Israel. Opthea is planning to enrol at least 108 patients into the Phase 2a study.

Patients are being randomly assigned in a 2:1 ratio to one of two treatment groups to investigate the clinical efficacy and safety of OPT-302 (2 mg) in combination with aflibercept (2 mg) compared to aflibercept monotherapy (2 mg). Treatments are administered on a monthly basis for 3 months via intravitreal (ocular) injection.

The trial is investigating if OPT-302 improves vision and retinal swelling in diabetics with persistent central-involved macular edema who are refractory and shown a suboptimal response to prior intravitreal anti-VEGF-A therapy.

Opthea anticipates reporting outcomes from the Phase 2a DME trial before the end of calendar year 2019, subject to patient recruitment.

More information can be found on the website (NCT #03397264).

Phase 1b Dose Escalation study of OPT-302 + Aflibercept in DME

Phase 1b Dose Escalation DME

Key Inclusion Criteria

  • Age ≥ 18 years; centre-involving DME
  • CST ≥ 335 µm*
  • BCVA 73 – 24 ETDRS letters (20/40 – 20/320 Snellen)
  • Prior exposure to anti-VEGF-A therapy with sub-optimal therapeutic response:
    – ≥ 3 intravitreal injections
    – Last injection ≤ 6 weeks prior to study day 1
    – Prior bevacizumab only allowed if switched to IVT aflibercept or ranibizumab prior to study

Key Exclusion Criteria

  • HbA1c ≥ 12%
  • Uncontrolled hypertension ≥ 180 mmHg systolic or ≥ 110 mmHg diastolic
  • Eyes needing PRP within 3 months of screening
  • Concurrent/prior use of intravitreal injections of steroids within 4 months of study start
  • Concurrent/prior use of dexamethasone or fluocinolone implant in study eye

*CST as measured by Spectralis (Heidelberg) at screening, ≥ 320 µm for Cirrus.