Clinical trials

Opthea is currently conducting two concurrent Phase 3 clinical trials with OPT-302 which are actively recruiting and enrolling treatment-naïve patients for the treatment of wet AMD.

The Phase 3 trials, referred to as ShORe and COAST, are double-masked, sham-controlled trials that enroll treatment-naïve patients and assess the efficacy and safety of 2.0 mg OPT-302 in combination with anti-VEGF-A therapy, compared to standard of care anti-VEGF-A monotherapy.

Wet AMD Clinical Trials

Opthea has initiated two concurrent Phase 3 clinical trials with OPT-302 which are actively recruiting and enrolling treatment-naïve patients for the treatment of wet AMD.

The Phase 3 trials, referred to as ShORe and COAST, are double-masked, sham-controlled trials that are actively recruiting and enrolling treatment-naïve patients to assess the efficacy and safety of 2.0 mg OPT-302 in combination with anti-VEGF-A therapy, compared to standard of care anti-VEGF-A monotherapy. In addition, to understand the durability of OPT-302 treatment effect with less frequent dosing, each trial will compare the clinical efficacy of OPT-302 administered in combination with the applicable VEGF-A inhibitor on an every 4-week and every 8-week dosing regimen.

Opthea has completed a randomised, controlled, double-masked Phase 2b clinical trial in 366 treatment-naïve wet AMD patients investigating the VEGF-A inhibitor Lucentis® (ranibizumab) administered in combination with OPT-302 compared to Lucentis® administered alone. The trial met the primary endpoint, with OPT-302 administered in combination with Lucentis® demonstrating a statistically significant superior mean gain in visual acuity over Lucentis monotherapy at week 24.

  • Phase 3 ShORe wet AMD clinical trial: OPT-302
  • Phase 3 COAST wet AMD clinical trial: OPT-302
  • Phase 2b wet AMD clinical trial: OPT-302-1002 (COMPLETED)
  • Phase 1/2a wet AMD clinical trial: OPT-302-1001 (COMPLETED)

DME Clinical Trials

Opthea has reported outcomes from a Phase 1b dose-escalation clinical trial of OPT-302 administered in combination with the VEGF-A inhibitor Eylea® (aflibercept).  Dose-responsive improvements in visual acuity were observed in patients treated with increasing doses of OPT-302 (0.3, 1.0, 2.0 mg) administered in combination with Eylea (2 mg).  Opthea has also reported outcomes from a Phase 2a clinical trial in patients with treatment-refractory, persistent DME, demonstrating improved clinical outcomes in patients treated with OPT-302 in combination with Eylea®.

  • Phase 1/2a DME clinical trial: OPT-302-1003 (COMPLETED)

OPT-302 Randomised controlled clinical trials in wet AMD & DME

Expanded Access Position Statement

At the current time, and in accordance with Opthea’s Expanded Access Policy, OPT-302 is not available for expanded access for the following reasons:

  • OPT-302 is an investigational product and is not approved for any indication in any market worldwide. OPT-302 is currently under investigation for Age-Related Macular Degeneration and Diabetic Macular Edema to determine if combination treatment of OPT-302 with standard of care anti-VEGF-A therapy has greater benefit than standard of care alone. It is not possible to determine whether addition of OPT-302 to anti-VEGF-A therapy has an improved benefit over standard of care treatment until completion of Phase 3 clinical trials.
  • Providing expanded access may interfere with clinical trial supply availability.

A copy of Opthea’s Expanded Access Policy is available here.

 

Additional information on Opthea’s technology and clinical trials can be found at ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636).