deltatrials
Terminated PHASE3 INTERVENTIONAL 3-arm NCT04757610

OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD) (ShORe)

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

Sponsor: Opthea Limited

Conditions Neovascular Age-related Macular Degeneration
Interventions 0.5 mg ranibizumab 2.0 mg OPT-302 Sham
Updated 21 times since 2021 Last updated: Jul 17, 2025 Started: Mar 12, 2021 Primary completion: Mar 31, 2025 Completion: Mar 31, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The primary endpoint was not achieved in the study.

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This PHASE3 trial investigates Neovascular Age-related Macular Degeneration and is currently terminated or withdrawn. Opthea Limited leads this study, which shows 21 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Dec 2023 · 15 months · monthly snapshot~Dec 2023 – ~Apr 2024 · 4 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~Aug 2025 · 3 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

21 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Aug 2025 — Sep 2025 [monthly]

    Terminated PHASE3

  3. May 2025 — Aug 2025 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

  4. Sep 2024 — May 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

▶ Show 16 earlier versions

  1. Apr 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  2. Dec 2023 — Apr 2024 [monthly]

    Recruiting PHASE3

  3. Sep 2022 — Dec 2023 [monthly]

    Recruiting PHASE3

  4. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  5. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  6. Apr 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  7. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  8. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  9. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  10. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  11. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  12. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  13. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  14. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  15. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  16. Mar 2021 — May 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Opthea Limited
Data source: Opthea Limited

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarhus, Denmark , Ahmedabad, India , Alcalá de Henares, Spain , Arlington, United States , Athens, Greece , Augusta, United States , Austin, United States , Bakersfield, United States , Baltimore, United States , Bangalore, India and 159 more locations