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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03397264




Registration number
NCT03397264
Ethics application status
Date submitted
1/01/2018
Date registered
5/01/2018
Date last updated
16/11/2018

Titles & IDs
Public title
A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
Scientific title
Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema
Secondary ID [1] 0 0
OPT-302-1003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Aflibercept
Other interventions - OPT-302
Other interventions - Sham intravitreal injection

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)

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)

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)

Experimental: Ph 2a: 2.0 mg aflibercept with highest tested or MTD OPT-302 - 2.0 mg aflibercept intravitreal injection (0.05 mL) followed highest tested or MTD from Phase 1b OPT-302 intravitreal injection (0.05 mL)

Sham Comparator: Ph 2a: 2.0 mg aflibercept with sham - 2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection


Other interventions: Aflibercept
Intravitreal injection

Other interventions: OPT-302
Intravitreal Injection

Other interventions: Sham intravitreal injection
Sham (mock) intravitreal injection

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline to Week 24
Primary outcome [2] 0 0
Phase 2a: Proportion of participants achieving at least a 5 letter gain in BCVA compared to Baseline - BCVA will be measured according to Early Treatment Diabetic Retinopathy Score criteria
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
BCVA - Mean change in Best Corrected Visual Acuity (BCVA)
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
CST - Mean change in central subfield thickness (CST) on spectral domain coherence tomography (SD-OCT)
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Macular Volume - Mean change in macular volume on spectral domain coherence tomography (SD-OCT)
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Reduction in Foveal Thickness - Percent of eyes with CST with 50% or more reduction in excess foveal thickness
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Improvement in Early Treatment Diabetic Retinopathy Study (ETDRS) Score - Percent of participants with a 2 step or more improvement in ETDRS Diabetic Retinopathy Score
Timepoint [5] 0 0
Baseline to Week 12
Secondary outcome [6] 0 0
Aflibercept (anti-Vascular Endothelial Growth Factor-A) Retreatment (Mean Time) - The mean time to re-treatment injections of aflibercept anti-VEGF-A therapy
Timepoint [6] 0 0
Week 12 to Week 24
Secondary outcome [7] 0 0
Aflibercept (anti-Vascular Endothelial Growth Factor-A) Retreatment (Number) - The number of re-treatment injections of aflibercept anti-VEGF-A therapy
Timepoint [7] 0 0
Week 12 to Week 24

Eligibility
Key inclusion criteria
- History of diabetic macular edema (DME) = 1 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Opthea Investigational Site - Parramatta
Recruitment hospital [2] 0 0
Opthea Investigational Site - Sydney
Recruitment hospital [3] 0 0
Opthea Investigational Site - Westmead
Recruitment hospital [4] 0 0
Opthea Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Parramatta
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Opthea Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT03397264
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director Opthea
Address 0 0
Country 0 0
Phone 0 0
+61 3 9826 0399
Fax 0 0
Email 0 0
OPT-302-1003-Clinicaltrial.gov@ppdi.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable