Phase 2B Wet AMD
Opthea has begun treating patients in a randomised, controlled Phase 2b clinical trial (OPT-302-1002) of OPT-302 in combination with ranibizumab (Lucentis®) for wet AMD.
Opthea plans to enrol 351 patients at sites in the US, Europe (United Kingdom, France, Poland, Hungary, Spain, Latvia, Italy and Czech Republic) and Israel.
Patients will be randomised in a 1:1:1 ratio (i.e. patients have an equal chance of being randomised to any of the groups) 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 monotherapy (0.5 mg). Treatments will be administered on a monthly basis for 6 months via intravitreal (ocular) injection.
The Phase 2b trial will be conducted in patients who have not yet 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 currently enrolling patients.
More information can be found on the ClinicalTrials.gov website (NCT #03345082).