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NCT Number: NCT03397264

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

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Opthea Investigational Site, Parramatta, New South Wales, Australia

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About this study

Study OPT-302-1003 was designed as a 2-part, multicenter study consisting of a Phase 1b open-label, sequential dose escalation followed by a Phase 2a randomized, parallel-group, sham-controlled, double-masked, dose-expansion evaluating intravitreal OPT-302 in combination with aflibercept in participants with persistent central-involved diabetic macula edema.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept

Biological

Intravitreal injection

Other names: Eylea

OPT-302

Biological

Intravitreal Injection

Sham intravitreal injection

Other

Sham (mock) intravitreal injection

Primary outcomes

  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 Defined as Proportion of Participants Receiving OPT-302 With Aflibercept Achieving at Least a 5-letter Gain in BCVA at Week 12

    Time frame: Baseline to Week 12

    Change from baseline in Best Corrected Visual Acuity (BCVA) will be measured at Week 12 according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Opthea Limited

Industry

Registry information

Official study title

Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2018
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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