Status:
COMPLETED
A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
Lead Sponsor:
Opthea Limited
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 a...
Detailed 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, doubl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2020
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03397264
Start Date
January 16 2018
End Date
June 11 2020
Last Update
April 22 2025
Active Locations (53)
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1
Opthea Investigational Site
Phoenix, Arizona, United States, 85014
2
Opthea Investigational Site
Bakersfield, California, United States, 93309
3
Opthea Investigational Site
Beverly Hills, California, United States, 90211
4
Opthea Investigational Site
Redlands, California, United States, 92374