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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Opthea Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Diabetic Macular Edema

Clinical Trials on Aflibercept

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings