A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
NCT ID: NCT03397264
Last Updated: 2025-04-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
153 participants
INTERVENTIONAL
2018-01-16
2020-06-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intravitreal Aflibercept Injection in Vision Impairment Due to DME
NCT01331681
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
NCT04603937
Diabetic Retinopathy Assessed by Ultra-wide
NCT03157206
Aflibercept Injection for Proliferative Diabetic Retinopathy
NCT01805297
Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema
NCT02874859
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Aflibercept
Intravitreal injection
OPT-302
Intravitreal Injection
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)
Aflibercept
Intravitreal injection
OPT-302
Intravitreal Injection
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)
Aflibercept
Intravitreal injection
OPT-302
Intravitreal Injection
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)
Aflibercept
Intravitreal injection
OPT-302
Intravitreal Injection
Ph 2a: 2.0 mg aflibercept with sham
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Aflibercept
Intravitreal injection
Sham intravitreal injection
Sham (mock) intravitreal injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aflibercept
Intravitreal injection
OPT-302
Intravitreal Injection
Sham intravitreal injection
Sham (mock) intravitreal injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Opthea Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director Opthea
Role: STUDY_DIRECTOR
Opthea Limited
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Opthea Investigational Site
Phoenix, Arizona, United States
Opthea Investigational Site
Bakersfield, California, United States
Opthea Investigational Site
Beverly Hills, California, United States
Opthea Investigational Site
Redlands, California, United States
Opthea Investigational Site
Sacramento, California, United States
Opthea Investigational Site
Santa Ana, California, United States
Opthea Investigational Site
Colorado Springs, Colorado, United States
Opthea Investigational Site
Boynton Beach, Florida, United States
Opthea Investigational Site
Fort Myers, Florida, United States
Opthea Investigational Site
Melbourne, Florida, United States
Opthea Investigational Site
Pensacola, Florida, United States
Opthea Investigational Site
St. Petersburg, Florida, United States
Opthea Investigational Site
Augusta, Georgia, United States
Opthea Investigational Site
Indianapolis, Indiana, United States
Opthea Investigational Site
Des Moines, Iowa, United States
Opthea Investigational Site
Wichita, Kansas, United States
Opthea Investigational Site
Hagerstown, Maryland, United States
Opthea Investigational Site
Las Vegas, Nevada, United States
Opthea Investigational Site
Reno, Nevada, United States
Opthea Investigational Site
Asheville, North Carolina, United States
Opthea Investigational Site
Charlotte, North Carolina, United States
Opthea Investigational Site
Youngstown, Ohio, United States
Opthea Investigational Site
Portland, Oregon, United States
Opthea Investigational Site
Charleston, South Carolina, United States
Opthea Investigational Site
West Columbia, South Carolina, United States
Opthea Investigational Site
Rapid City, South Dakota, United States
Opthea Investigational Site
Germantown, Tennessee, United States
Opthea Investigational Site
Abilene, Texas, United States
Opthea Investigational Site
Arlington, Texas, United States
Opthea Investigational Site
Austin, Texas, United States
Opthea Investigational Site
Houston, Texas, United States
Opthea Investigational Site
McAllen, Texas, United States
Opthea Investigational Site
San Antonio, Texas, United States
Opthea Investigational Site
Willow Park, Texas, United States
Opthea Investigational Site
Parramatta, New South Wales, Australia
Opthea Investigational Site
Sydney, New South Wales, Australia
Opthea Investigational Site
Westmead, New South Wales, Australia
Opthea Investigational Site
Perth, Western Australia, Australia
Opthea Investigational Site
Be’er Ya‘aqov, , Israel
Opthea Investigational Site
Haifa, , Israel
Opthea Investigational Site
Haifa, , Israel
Opthea Investigational Site
Haifa, , Israel
Opthea Investigational Site
Jerusalem, , Israel
Opthea Investigational Site
Jerusalem, , Israel
Opthea Investigational Site
Kfar Saba, , Israel
Opthea Investigational Site
Petah Tikva, , Israel
Opthea Investigational Site
Rehovot, , Israel
Opthea Investigational Site
Tel Aviv, , Israel
Opthea Investigational Site
Tiberias, , Israel
Opthea Investigational Site
Jelgava, , Latvia
Opthea Investigational Site
Riga, , Latvia
Opthea Investigational Site
Riga, , Latvia
Opthea Investigational Site
Riga, , Latvia
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OPT-302-1003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.