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NCT03397264 Clinical Trial

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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03397264
Other study ID # OPT-302-1003
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 16, 2018
Est. completion date June 11, 2020

Study information
Verified date May 2022
Source Opthea Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 153
Est. completion date June 11, 2020
Est. primary completion date March 26, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Aflibercept
Intravitreal injection
• OPT-302
Intravitreal Injection
Other:
• Sham intravitreal injection
Sham (mock) intravitreal injection

Locations
Country Name City State
Australia Opthea Investigational Site Parramatta New South Wales
Australia Opthea Investigational Site Perth Western Australia
Australia Opthea Investigational Site Sydney New South Wales
Australia Opthea Investigational Site Westmead New South Wales
Israel 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 Re?ovot
Israel Opthea Investigational Site Tel Aviv Yafo
Israel Opthea Investigational Site Tiberias
Latvia Opthea Investigational Site Jelgava
Latvia Opthea Investigational Site Riga
Latvia Opthea Investigational Site Riga
Latvia Opthea Investigational Site Riga
United States Opthea Investigational Site Abilene Texas
United States Opthea Investigational Site Arlington Texas
United States Opthea Investigational Site Asheville North Carolina
United States Opthea Investigational Site Augusta Georgia
United States Opthea Investigational Site Austin Texas
United States Opthea Investigational Site Bakersfield California
United States Opthea Investigational Site Beverly Hills California
United States Opthea Investigational Site Boynton Beach Florida
United States Opthea Investigational Site Charleston South Carolina
United States Opthea Investigational Site Charlotte North Carolina
United States Opthea Investigational Site Colorado Springs Colorado
United States Opthea Investigational Site Des Moines Iowa
United States Opthea Investigational Site Fort Myers Florida
United States Opthea Investigational Site Germantown Tennessee
United States Opthea Investigational Site Hagerstown Maryland
United States Opthea Investigational Site Houston Texas
United States Opthea Investigational Site Indianapolis Indiana
United States Opthea Investigational Site Las Vegas Nevada
United States Opthea Investigational Site McAllen Texas
United States Opthea Investigational Site Melbourne Florida
United States Opthea Investigational Site Pensacola Florida
United States Opthea Investigational Site Phoenix Arizona
United States Opthea Investigational Site Portland Oregon
United States Opthea Investigational Site Rapid City South Dakota
United States Opthea Investigational Site Redlands California
United States Opthea Investigational Site Reno Nevada
United States Opthea Investigational Site Sacramento California
United States Opthea Investigational Site Saint Petersburg Florida
United States Opthea Investigational Site San Antonio Texas
United States Opthea Investigational Site Santa Ana California
United States Opthea Investigational Site West Columbia South Carolina
United States Opthea Investigational Site Wichita Kansas
United States Opthea Investigational Site Willow Park Texas
United States Opthea Investigational Site Youngstown Ohio

Sponsors (1)
Lead Sponsor Collaborator
Opthea Limited

Countries where clinical trial is conducted

United States,  Australia,  Israel,  Latvia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) 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
Primary Phase 2a: Response Rate as Defined by Proportion of Participants Receiving Combination of OPT-302 and Aflibercept Achieving at Least a 5-letter Gain in BCVA Compared to Baseline at Week 12 According to ETDRS Criteria BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria Baseline to Week 12
Secondary Mean Change in BCVA 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
Secondary Mean Change in CST Mean change in central subfield thickness (CST) on spectral domain coherence tomography (SD-OCT) Baseline to Week 12
See also
  Status Clinical Trial Phase
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Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Active, not recruiting NCT04108156 - This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab Phase 3
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