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

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ClinicalTrials.gov Identifier: NCT03397264
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Opthea Limited

Tracking Information
First Submitted Date  ICMJE January 1, 2018
First Posted Date  ICMJE January 11, 2018
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE December 15, 2017
Estimated Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Baseline to Week 24 ]
    Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0
  • Phase 2a: Proportion of participants achieving at least a 5 letter gain in BCVA compared to Baseline [ Time Frame: Baseline to Week 12 ]
    BCVA will be measured according to Early Treatment Diabetic Retinopathy Score criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03397264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • BCVA [ Time Frame: Baseline to Week 12 ]
    Mean change in Best Corrected Visual Acuity (BCVA)
  • CST [ Time Frame: Baseline to Week 12 ]
    Mean change in central subfield thickness (CST) on spectral domain coherence tomography (SD-OCT)
  • Macular Volume [ Time Frame: Baseline to Week 12 ]
    Mean change in macular volume on spectral domain coherence tomography (SD-OCT)
  • Reduction in Foveal Thickness [ Time Frame: Baseline to Week 12 ]
    Percent of eyes with CST with 50% or more reduction in excess foveal thickness
  • Improvement in Early Treatment Diabetic Retinopathy Study (ETDRS) Score [ Time Frame: Baseline to Week 12 ]
    Percent of participants with a 2 step or more improvement in ETDRS Diabetic Retinopathy Score
  • Aflibercept (anti-Vascular Endothelial Growth Factor-A) Retreatment (Mean Time) [ Time Frame: Week 12 to Week 24 ]
    The mean time to re-treatment injections of aflibercept anti-VEGF-A therapy
  • Aflibercept (anti-Vascular Endothelial Growth Factor-A) Retreatment (Number) [ Time Frame: Week 12 to Week 24 ]
    The number of re-treatment injections of aflibercept anti-VEGF-A therapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
Official Title  ICMJE Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase 1b - sequential dose followed by Phase 2a - parallel arm
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Ph 1b open label; Ph 2a quadruple masked
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Biological: Aflibercept
    Intravitreal injection
    Other Name: Eylea
  • Biological: OPT-302
    Intravitreal Injection
  • Other: Sham intravitreal injection
    Sham (mock) intravitreal injection
Study Arms  ICMJE
  • 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)
    Interventions:
    • Biological: Aflibercept
    • Biological: OPT-302
  • 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)
    Interventions:
    • Biological: Aflibercept
    • Biological: OPT-302
  • 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)
    Interventions:
    • Biological: Aflibercept
    • Biological: OPT-302
  • 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)
    Interventions:
    • Biological: Aflibercept
    • Biological: OPT-302
  • Sham Comparator: Ph 2a: 2.0 mg aflibercept with sham
    2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
    Interventions:
    • Biological: Aflibercept
    • Other: Sham intravitreal injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2018)
117
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Opthea OPT-302-1003-Clinicaltrial.gov@ppdi.com
Listed Location Countries  ICMJE United States,   Australia,   Israel,   Latvia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03397264
Other Study ID Numbers  ICMJE OPT-302-1003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Opthea Limited
Study Sponsor  ICMJE Opthea Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Opthea Limited
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP