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Opthea - Persistent Diabetic Macular Edema (DME)

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

Study Description:

Condition or Disease

Intervention / Treatment

Phase

Sponsor

Status

Diabetic
Macular Edema

Biological:  Aflibercept
Biological:  OPT-302
Other:  Sham Injection

Phase 1 & 2

Opthea

Currently Enrolling

 

 

 

 

 

Purpose:  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.

Eligibility Criteria:

  • Ages Eligible for Study - 18 Years and Older.
  • Sexes Eligible for Study - All.

Inclusion Criteria:

  • History of diabetic macular edema (DME) ≤ 1 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.
  • Vision 20/40 to 20/320.  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:  Youngstown Office:  John Lacombe 330-759-8777  •  jlacombe@retina-assoc.com.

To learn more: https://clinicaltrials.gov/ct2/show/NCT03397264