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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03397264




Registration number
NCT03397264
Ethics application status
Date submitted
1/01/2018
Date registered
11/01/2018
Date last updated
22/06/2022

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
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

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 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)

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)
Timepoint [1] 0 0
Baseline to Week 12
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Mean Change in BCVA
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Mean Change in CST
Timepoint [2] 0 0
Baseline to Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/06/2020
Sample size
Target
Accrual to date
Final
153
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
Country [18] 0 0
Israel
State/province [18] 0 0
Be'er Ya'aqov
Country [19] 0 0
Israel
State/province [19] 0 0
Haifa
Country [20] 0 0
Israel
State/province [20] 0 0
Jerusalem
Country [21] 0 0
Israel
State/province [21] 0 0
Kfar Saba
Country [22] 0 0
Israel
State/province [22] 0 0
Petah Tikva
Country [23] 0 0
Israel
State/province [23] 0 0
Re?ovot
Country [24] 0 0
Israel
State/province [24] 0 0
Tel Aviv Yafo
Country [25] 0 0
Israel
State/province [25] 0 0
Tiberias
Country [26] 0 0
Latvia
State/province [26] 0 0
Jelgava
Country [27] 0 0
Latvia
State/province [27] 0 0
Riga

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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03397264