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A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

NCT03345082 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2021-01-12

No results posted yet for this study

Summary

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

BIOLOGICAL

OPT-302

Intravitreal injection

BIOLOGICAL

ranibizumab

Intravitreal injection

OTHER

sham intravitreal injection

Sham (mock) intravitreal injection

Sponsors & Collaborators

  • Opthea Limited

    lead INDUSTRY

Principal Investigators

  • Study Director · Opthea Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2019-05-14
Completion
2019-05-14
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03345082 on ClinicalTrials.gov