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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

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

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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



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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
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Contact: Study Opthea OPT-302-1003-Clinicaltrial.gov@ppdi.com

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Locations
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United States, Arizona
Opthea Investigational Site Recruiting
Phoenix, Arizona, United States, 85014
Contact: Study Manager         
United States, California
Opthea Investigational Site Recruiting
Bakersfield, California, United States, 93309
Contact: Study Manager         
Opthea Investigational Site Recruiting
Beverly Hills, California, United States, 90211
Contact: Study Manager         
Opthea Investigational Site Recruiting
Redlands, California, United States, 92374
Opthea Investigational Site Recruiting
Sacramento, California, United States, 95819
Contact: Study Manager         
Opthea Investigational Site Recruiting
Santa Ana, California, United States, 92705
United States, Colorado
Opthea Investigational Site Recruiting
Colorado Springs, Colorado, United States, 30909
Contact: Study Manager         
United States, Florida
Opthea Investigational Site Recruiting
Boynton Beach, Florida, United States, 33426
Opthea Investigational Site Recruiting
Fort Myers, Florida, United States, 33912
Contact: Study Manager         
Opthea Investigational Site Recruiting
Melbourne, Florida, United States, 32901
Contact: Study Manager         
Opthea Investigational Site Recruiting
Pensacola, Florida, United States, 32503
Contact: Study Manager         
Opthea Investigational Site Recruiting
Saint Petersburg, Florida, United States, 33711
United States, Georgia
Opthea Investigational Site Recruiting
Augusta, Georgia, United States, 30909
United States, Indiana
Opthea Investigational Site Recruiting
Indianapolis, Indiana, United States, 46290
United States, Iowa
Opthea Investigational Site Recruiting
Des Moines, Iowa, United States, 50266
United States, Kansas
Opthea Investigational Site Recruiting
Wichita, Kansas, United States, 67214
Contact: Study Manager         
United States, Maryland
Opthea Investigational Site Recruiting
Hagerstown, Maryland, United States, 21740
United States, Nevada
Opthea Investigational Site Recruiting
Las Vegas, Nevada, United States, 89144
Opthea Investigational Site Recruiting
Reno, Nevada, United States, 89502
United States, North Carolina
Opthea Investigational Site Recruiting
Asheville, North Carolina, United States, 28803
Contact: Study Manager         
Opthea Investigational Site Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Study Manager         
United States, Ohio
Opthea Investigational Site Recruiting
Youngstown, Ohio, United States, 92705
Contact: Study Name         
United States, Oregon
Opthea Investigational Site Recruiting
Portland, Oregon, United States, 97213
United States, South Carolina
Opthea Investigational Site Recruiting
Charleston, South Carolina, United States, 29414
Opthea Investigational Site Recruiting
West Columbia, South Carolina, United States, 29169
Contact: Study Manager         
United States, South Dakota
Opthea Investigational Site Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Opthea Investigational Site Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Opthea Investigational Site Recruiting
Abilene, Texas, United States, 79606
Contact: Study Manager         
Opthea Investigational Site Recruiting
Arlington, Texas, United States, 76012
Opthea Investigational Site Recruiting
Austin, Texas, United States, 78705
Opthea Investigational Site Recruiting
Houston, Texas, United States, 77030
Opthea Investigational Site Recruiting
McAllen, Texas, United States, 78503
Opthea Investigational Site Recruiting
San Antonio, Texas, United States, 78240
Contact: Study Manager         
Opthea Investigational Site Recruiting
Willow Park, Texas, United States, 76087
Australia, New South Wales
Opthea Investigational Site Recruiting
Parramatta, New South Wales, Australia
Contact: Study Manager         
Opthea Investigational Site Recruiting
Sydney, New South Wales, Australia
Contact: Study Manager         
Opthea Investigational Site Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Western Australia
Opthea Investigational Site Recruiting
Perth, Western Australia, Australia
Israel
Opthea Investigational Site Recruiting
Be'er Ya'aqov, Israel, 703 5
Opthea Investigational Site Recruiting
Haifa, Israel, 31048
Opthea Investigational Site Recruiting
Haifa, Israel, 31096
Opthea Investigational Site Recruiting
Haifa, Israel, 34362
Opthea Investigational Site Recruiting
Jerusalem, Israel, 91031
Opthea Investigational Site Recruiting
Jerusalem, Israel, 91120
Opthea Investigational Site Recruiting
Kfar Saba, Israel, 44281
Opthea Investigational Site Recruiting
Petah Tikva, Israel, 49100
Opthea Investigational Site Recruiting
Reẖovot, Israel, 76100
Opthea Investigational Site Recruiting
Tel Aviv Yafo, Israel, 64239
Opthea Investigational Site Recruiting
Tiberias, Israel, 15208
Latvia
Opthea Investigational Site Recruiting
Jelgava, Latvia, LV-3001
Opthea Investigational Site Recruiting
Riga, Latvia, LV-1002
Opthea Investigational Site Recruiting
Riga, Latvia, LV-1006
Opthea Investigational Site Recruiting
Riga, Latvia, LV-1050
Sponsors and Collaborators
Opthea Limited

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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