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

Conditions

• Diabetic Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept — BIOLOGICAL
  Intravitreal injection
• OPT-302 — BIOLOGICAL
  Intravitreal Injection
• Sham intravitreal injection — OTHER
  Sham (mock) intravitreal injection

Study Details

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.

Key Dates

Start date

Jan 16, 2018

Status verified

Apr 2025

Primary completion

Mar 26, 2020

Completion

Jun 11, 2020

Study Design

Enrollment

153 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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)
• 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)
• 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)
• 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)
• Sham Comparator: Ph 2a: 2.0 mg aflibercept with sham
  2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Baseline to Week 12 ]

Locations (34)

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