A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)
Phase of Trial: Phase II
Latest Information Update: 10 Apr 2018
At a glance
- Drugs OPT 302 (Primary) ; Ranibizumab
- Indications Wet age-related macular degeneration
- Focus Therapeutic Use
- Sponsors Opthea
- 27 Mar 2018 According to an Opthea media release, the company conducted The Investigators Meeting European and Israeli Investigators and site staff involved in this trial to review the trial protocol and patient eligibility criteria. The company has Opthea conducted a similar US Investigators Meeting in Dallas Texas in October 2017, prior to initiation of patient enrolment at US sites. Primary analysis of the data from the study is anticipated in early 2020.
- 27 Mar 2018 According to an Opthea media release, the randomization and dosing of patients in these jurisdictions follows successful regulatory interactions with the each of the participating European countries regulatory agencies via the European Voluntary Harmonisation Process (VHP), the Ministry of Health in Israel and the US Food & Drug Administration (FDA).
- 27 Mar 2018 According to an Opthea media release, the company has expanded recruitment for the study into another 9 countries followed by Investigators Meeting on 16th March 2018. The company is planning o open a total of 6 trial sites in Israel and over 50 trial sites across eight European countries, consisting of the United Kingdom, France, Poland, Hungary, Spain, Latvia, Italy and the Czech Republic.