OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD) (ShORe)
OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD) (ShORe)
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD
Estimated Study Start Date: March 2021
Estimated Primary Completion Date: December 2023
Estimated Study Completion Date: December 2024
Arm:
- Experimental: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302
- Experimental: 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302
- Sham Comparator: 0.5 mg ranibizumab with sham
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 990 |
| Estimated Study start date | 01 March 2021 |
| Estimated Study Completion Date | 01 December 2024 |