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
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

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