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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03397264
Recruitment Status : Completed
First Posted : January 11, 2018
Results First Posted : June 22, 2022
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Opthea Limited

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 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 : January 16, 2018
Actual Primary Completion Date : March 26, 2020
Actual Study Completion Date : June 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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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 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
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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Baseline to Week 12 ]
    Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)

  2. 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 [ Time Frame: Baseline to Week 12 ]
    BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria


Secondary Outcome Measures :
  1. Mean Change in BCVA [ Time Frame: Baseline to Week 12 ]
    Mean change in Best Corrected Visual Acuity (BCVA). BCVA will be measured according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria

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


Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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


Locations
Show Show 53 study locations
Sponsors and Collaborators
Opthea Limited
  Study Documents (Full-Text)

Documents provided by Opthea Limited:
Study Protocol  [PDF] August 2, 2018
Statistical Analysis Plan  [PDF] May 18, 2020

More Information
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Responsible Party: Opthea Limited
ClinicalTrials.gov Identifier: NCT03397264    
Other Study ID Numbers: OPT-302-1003
First Posted: January 11, 2018    Key Record Dates
Results First Posted: June 22, 2022
Last Update Posted: June 22, 2022
Last Verified: May 2022

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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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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents