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A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

NCT03397264 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-04-22

Study results available
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Summary

A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.

Conditions

Interventions

BIOLOGICAL

Aflibercept

Intravitreal injection

BIOLOGICAL

OPT-302

Intravitreal Injection

OTHER

Sham intravitreal injection

Sham (mock) intravitreal injection

Sponsors & Collaborators

  • Opthea Limited

    lead INDUSTRY

Principal Investigators

  • Study Director Opthea · Opthea Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2020-03-26
Completion
2020-06-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Israel
  • Latvia

Study Locations

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Entities

Drugs
Diseases

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 NCT03397264 on ClinicalTrials.gov