Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Opthea OPT302-1003
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Biological: Aflibercept Biological: OPT-302 Other: Sham intravitreal injection Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
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
Official Title: Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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)
Biological: Aflibercept
Intravitreal injection
Other Name: Eylea

Biological: OPT-302
Intravitreal Injection

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)
Biological: Aflibercept
Intravitreal injection
Other Name: Eylea

Biological: OPT-302
Intravitreal Injection

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)
Biological: Aflibercept
Intravitreal injection
Other Name: Eylea

Biological: OPT-302
Intravitreal Injection

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)
Biological: Aflibercept
Intravitreal injection
Other Name: Eylea

Biological: OPT-302
Intravitreal Injection

Sham Comparator: Ph 2a: 2.0 mg aflibercept with sham
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Biological: Aflibercept
Intravitreal injection
Other Name: Eylea

Other: Sham intravitreal injection
Sham (mock) intravitreal injection




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. BCVA [ Time Frame: Baseline to Week 12 ]
    Mean change in Best Corrected Visual Acuity (BCVA)

  2. CST [ Time Frame: Baseline to Week 12 ]
    Mean change in central subfield thickness (CST) on spectral domain coherence tomography (SD-OCT)

  3. Macular Volume [ Time Frame: Baseline to Week 12 ]
    Mean change in macular volume on spectral domain coherence tomography (SD-OCT)

  4. Reduction in Foveal Thickness [ Time Frame: Baseline to Week 12 ]
    Percent of eyes with CST with 50% or more reduction in excess foveal thickness

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397264


Contacts
Layout table for location contacts
Contact: Study Opthea OPT-302-1003-Clinicaltrial.gov@ppdi.com

  Show 53 Study Locations
Sponsors and Collaborators
Opthea Limited

Layout table for additonal information
Responsible Party: Opthea Limited
ClinicalTrials.gov Identifier: NCT03397264     History of Changes
Other Study ID Numbers: OPT-302-1003
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases