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

Opthea

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Biological: OPT-302; Biological: Aflibercept; Other: Sham intravitreal injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03397264

OPT-302-1003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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153 participants in 5 patient groups

Ph 1b: 2.0 mg aflibercept with 0.3 mg OPT-302

Experimental group

Description:

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)

Treatment:

Biological: OPT-302

Biological: Aflibercept

Ph 1b: 2.0 mg aflibercept with 1.0 mg OPT-302

Experimental group

Description:

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)

Treatment:

Biological: OPT-302

Biological: Aflibercept

Ph 1b: 2.0 mg aflibercept with 2.0 mg OPT-302

Experimental group

Description:

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)

Treatment:

Biological: OPT-302

Biological: Aflibercept

Ph 2a: 2.0 mg aflibercept with 2.0 mg OPT-302

Experimental group

Description:

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)

Treatment:

Biological: OPT-302

Biological: Aflibercept

Ph 2a: 2.0 mg aflibercept with sham

Sham Comparator group

Description:

2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection

Treatment:

Other: Sham intravitreal injection

Biological: Aflibercept