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NCT04757610 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Opthea Limited.

Terminated
Registry status
Phase 3
Development phase
986
Enrollment target

NCT04757610: Clinical Trial Phase 3 study, sponsored by Opthea Limited.

NCT04757610 is a Phase 3 study that was terminated before completion, run by Opthea Limited. The registered enrollment target is 986 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04757610, a Phase 3 study, was terminated before completion, sponsored by Opthea Limited.

TERMINATED
Registry status
Phase 3
Development phase
986 participants
Enrollment target

Study Summary

A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Primary Outcome

To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome me

Interventions

  • PROCEDURE Sham
  • BIOLOGICAL 2.0 mg OPT-302
  • BIOLOGICAL 0.5 mg ranibizumab

Trial Details

FieldValue
Enrollment Target 986 participants
Start Date 2021-03-12
Est. Completion 2025-03-31
Phase Phase 3
Opthea Limited

5 total trials

Why NCT04757610 stopped before completion

NCT04757610 is an interventional study that assigns participants to a tested intervention. The registered 986 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher).

The record links to 0 conditions, and to 3 interventions - of which Sham is the first listed.

NCT04757610 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04757610 about?

NCT04757610 is a clinical study titled "OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)". A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

What is the current status of trial NCT04757610?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 986 participants. The study started on 2021-03-12. Estimated completion is 2025-03-31.

What interventions are being tested in trial NCT04757610?

The interventions under investigation include: Sham (PROCEDURE), 2.0 mg OPT-302 (BIOLOGICAL), 0.5 mg ranibizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04757610?

This trial is sponsored by Opthea Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04757610's enrollment target sits among peer trials

986 320th of 2000 higher than 1,681 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04757610, the US trial registry maintained by the National Library of Medicine. NCT04757610 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.