The final patient in Opthea’s Phase 2b trial of OPT-302 for wet age-related macular degeneration (AMD) has completed their last clinical visit, paving the way for reporting of top line results.
Patients enrolled in the doublemasked Phase 2b trial received intravitreal injections of OPT302, a selective VEGF-C/D ‘trap’ therapy, administered in combination with the VEGF-A inhibitor ranibizumab (Lucentis) or ranibizumab alone, on a monthly basis for six months. The final clinical visit was scheduled at week 24, one month after the final dose administration.
Of the 366 patients randomised in the trial, 348 (95.1%) patients completed the week 24 visit. The trial enrolled treatmentnaïve patients and was designed to investigate whether the addition of OPT-302 to ranibizumab therapy over a six month dosing period improves visual acuity and anatomical parameters including reductions in retinal thickness, as assessed by a central independent imaging reading centre.
“This milestone brings us closer to assessing the potential of OPT-302 combination treatment to improve vision and ocular anatomical outcomes in wet AMD patients receiving standard of care anti-VEGF-A monotherapy,” said Dr Megan Baldwin, Opthea CEO and Managing Director.
“We now look forward to reporting outcomes from the Phase 2b trial given encouraging previously reported Phase 1/2a study data as well as the scientific rationale for targeted inhibition of VEGF-C/D, two important regulators of aberrant retinal vessel growth and vascular leakage, which are implicated in mediating resistance to selective VEGF-A inhibitors.”