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

April 15, 2025 updated by: Opthea Limited

Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study OPT-302-1003 was designed as a 2-part, multicenter study consisting of a Phase 1b open-label, sequential dose escalation followed by a Phase 2a randomized, parallel-group, sham-controlled, double-masked, dose-expansion evaluating intravitreal OPT-302 in combination with aflibercept in participants with persistent central-involved diabetic macula edema.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Parramatta, New South Wales, Australia
        • Opthea Investigational Site
      • Sydney, New South Wales, Australia
        • Opthea Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Opthea Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia
        • Opthea Investigational Site
  • Israel
      • Be'er Ya'aqov, Israel, 703 5
        • Opthea Investigational Site
      • Haifa, Israel, 31048
        • Opthea Investigational Site
      • Haifa, Israel, 31096
        • Opthea Investigational Site
      • Haifa, Israel, 34362
        • Opthea Investigational Site
      • Jerusalem, Israel, 91031
        • Opthea Investigational Site
      • Jerusalem, Israel, 91120
        • Opthea Investigational Site
      • Kfar Saba, Israel, 44281
        • Opthea Investigational Site
      • Petah Tikva, Israel, 49100
        • Opthea Investigational Site
      • Reẖovot, Israel, 76100
        • Opthea Investigational Site
      • Tel Aviv Yafo, Israel, 64239
        • Opthea Investigational Site
      • Tiberias, Israel, 15208
        • Opthea Investigational Site
  • Latvia
      • Jelgava, Latvia, LV-3001
        • Opthea Investigational Site
      • Riga, Latvia, LV-1002
        • Opthea Investigational Site
      • Riga, Latvia, LV-1006
        • Opthea Investigational Site
      • Riga, Latvia, LV-1050
        • Opthea Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Opthea Investigational Site
    • California
      • Bakersfield, California, United States, 93309
        • Opthea Investigational Site
      • Beverly Hills, California, United States, 90211
        • Opthea Investigational Site
      • Redlands, California, United States, 92374
        • Opthea Investigational Site
      • Sacramento, California, United States, 95819
        • Opthea Investigational Site
      • Santa Ana, California, United States, 92705
        • Opthea Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 30909
        • Opthea Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Opthea Investigational Site
      • Fort Myers, Florida, United States, 33912
        • Opthea Investigational Site
      • Melbourne, Florida, United States, 32901
        • Opthea Investigational Site
      • Pensacola, Florida, United States, 32503
        • Opthea Investigational Site
      • Saint Petersburg, Florida, United States, 33711
        • Opthea Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Opthea Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Opthea Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Opthea Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Opthea Investigational Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Opthea Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Opthea Investigational Site
      • Reno, Nevada, United States, 89502
        • Opthea Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Opthea Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Opthea Investigational Site
    • Ohio
      • Youngstown, Ohio, United States, 92705
        • Opthea Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Opthea Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Opthea Investigational Site
      • West Columbia, South Carolina, United States, 29169
        • Opthea Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Opthea Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Opthea Investigational Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Opthea Investigational Site
      • Arlington, Texas, United States, 76012
        • Opthea Investigational Site
      • Austin, Texas, United States, 78705
        • Opthea Investigational Site
      • Houston, Texas, United States, 77030
        • Opthea Investigational Site
      • McAllen, Texas, United States, 78503
        • Opthea Investigational Site
      • San Antonio, Texas, United States, 78240
        • Opthea Investigational Site
      • Willow Park, Texas, United States, 76087
        • Opthea Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of diabetic macular edema (DME) ≤ 2 year
  • Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response
  • Three or more prior anti-VEGF-A therapy intravitreal injections
  • EDTRS BCVA score ≤ 73 and ≥ 24 letters

Exclusion Criteria:

  • Ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
  • HbA1c ≥ 12% and/or recent signs of uncontrolled diabetes
  • Any clinically significant disorder or condition or disease (e.g. cardiovascular, renal conditions) that would make the participant unsuitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ph 1b: 2.0 mg aflibercept with 0.3 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Biological: Aflibercept
Intravitreal injection
Other Names:
  • Eylea
Biological: OPT-302
Intravitreal Injection
Experimental: Ph 1b: 2.0 mg aflibercept with 1.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Biological: Aflibercept
Intravitreal injection
Other Names:
  • Eylea
Biological: OPT-302
Intravitreal Injection
Experimental: Ph 1b: 2.0 mg aflibercept with 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Biological: Aflibercept
Intravitreal injection
Other Names:
  • Eylea
Biological: OPT-302
Intravitreal Injection
Experimental: Ph 2a: 2.0 mg aflibercept with 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Biological: Aflibercept
Intravitreal injection
Other Names:
  • Eylea
Biological: OPT-302
Intravitreal Injection
Sham Comparator: Ph 2a: 2.0 mg aflibercept with sham
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Biological: Aflibercept
Intravitreal injection
Other Names:
  • Eylea
Other: Sham intravitreal injection
Sham (mock) intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: Baseline to Week 12
Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)
Baseline to Week 12
Phase 2a: Response Rate Defined as Proportion of Participants Receiving OPT-302 With Aflibercept Achieving at Least a 5-letter Gain in BCVA at Week 12
Time Frame: Baseline to Week 12
Change from baseline in Best Corrected Visual Acuity (BCVA) will be measured at Week 12 according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in BCVA
Time Frame: Baseline to Week 12
Mean change in Best Corrected Visual Acuity (BCVA). BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
Baseline to Week 12
Mean Change in CST
Time Frame: Baseline to Week 12
Mean change in central subfield thickness (CST) on spectral domain coherence tomography (SD-OCT)
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Opthea Limited

Investigators

  • Study Director: Study Director Opthea, Opthea Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2018

Primary Completion (Actual)

March 26, 2020

Study Completion (Actual)

June 11, 2020

Study Registration Dates

First Submitted

January 1, 2018

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPT-302-1003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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