A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

Phase 2 Completed 366 enrolled Opthea Limited

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Timeline

Start: 2017-11-06
Primary completion: 2019-05-14
Completion: 2019-05-14

Outcome

Met primary endpoint

paper 2.0 mg OPT-302 group was significantly superior to sham (+14.2 ± 11.61 vs. +10.8 ± 11.52 letters; P = 0.01). PMID 36754174 ↗

Publications

Jackson TL, Slakter J, Buyse M, Wang K, Dugel PU, Wykoff CC, Boyer DS, Gerometta M, Baldwin ME, Price CF; Opthea Study Group Investigators. A Randomized Controlled Trial of OPT-302, a VEGF-C/D Inhibitor for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2023 Jun;130(6):588-597. doi: 10.1016/j.ophtha.2023.02.001. Epub 2023 Feb 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SOZINIBERCEPT	Protein / enzyme biologic	0.5 mg	Intravitreal
Subject	SOZINIBERCEPT	Protein / enzyme biologic	2 mg	Intravitreal
Background	Ranibizumab	Monoclonal antibody	0.5 mg	Intravitreal