Phase 1b/2a DME
Opthea is investigating OPT-302 administered in combination with anti-vascular endothelial growth factor A (anti-VEGF-A) therapy for the treatment of persistent / refractory central-involved diabetic macular edema (DME).
Opthea has begun treating patients in a two part multi-centre Phase 1b/2a clinical trial (OPT-302-1003) consisting of a sequential dose escalation (Phase 1b) followed by a randomised, controlled dose expansion (Phase 2a) evaluating intravitreal OPT-302 in combination with aflibercept (Eylea®) in patients with persistent central-involved DME.
Phase 1b – Dose Escalation
The Phase 1b dose escalation is aimed at determining the maximum tolerated dose or highest dose tested, safety, pharmacokinetics and pharmacodynamics of OPT-302 in combination with aflibercept.
The Phase 1b will enrol 3 to 4 patients into three treatment cohorts of sequential, escalating dose levels of OPT-302 (0.3, 1 mg and 2 mg) each used in combination with aflibercept (2 mg). OPT-302 and aflibercept will be administered as separate intravitreal (ocular) injections on a monthly basis for 3 months.
The Phase 1b dose escalation is currently enrolling patients at sites in the US.
For more information, see the ClinicalTrials.gov website (NCT #03397264).
Phase 2a – Randomised Dose Expansion
The Phase 2a randomized, controlled dose expansion will enrol at least 108 patients and will begin once the dose level of OPT-302 has been determined following assessment of emerging safety data from the Phase 1b dose escalation.
Patients will be randomly assigned in a 2:1 ratio to one of two treatment groups to investigate the clinical efficacy and safety of OPT-302 in combination with aflibercept (0.5 mg) compared to aflibercept monotherapy (0.5 mg).
Treatments will be administered on a monthly basis for 3 months via intravitreal (ocular) injection.
The trial will be conducted in diabetic patients aged ≥ 18 years of age with persistent central-involved macular edema who are refractory and shown a suboptimal response to prior intravitreal anti-VEGF-A therapy.
The Phase 2a randomised, controlled dose expansion will enrol patients from US and Australian sites.
More information can be found on the ClinicalTrials.gov website (NCT #03397264).