MedTrace Logo

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

NCT04757636 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 998

Last updated 2025-08-05

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

BIOLOGICAL

2.0 mg OPT-302

intravitreal injection

BIOLOGICAL

2.0 aflibercept

intravitreal injection

PROCEDURE

Sham

intravitreal injection

Sponsors & Collaborators

  • Opthea Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Philippines
  • Poland
  • Puerto Rico
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04757636 on ClinicalTrials.gov