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



Status:Recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:December 15, 2017
End Date:June 1, 2019
Contact:Study Opthea
Email:OPT-302-1003-Clinicaltrial.gov@ppdi.com

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


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
We found this trial at
35
sites
Portland, Oregon 97239
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Abilene, Texas 79606
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Arlington, Texas 76012
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Arlington, TX
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Asheville, North Carolina 28803
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Augusta, Georgia 30909
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Augusta, GA
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Austin, Texas 78705
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Austin, TX
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Bakersfield, California 93309
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Beverly Hills, California 90211
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Boynton Beach, Florida 33426
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Charleston, South Carolina 29414
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Charleston, SC
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Charlotte, North Carolina 28210
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Charlotte, NC
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Colorado Springs, Colorado 80909
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Colorado Springs, CO
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Des Moines, Iowa 50266
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Des Moines, IA
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Fort Myers, Florida 33912
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Fort Myers, FL
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Germantown, Tennessee 38138
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Germantown, TN
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Hagerstown, Maryland 21740
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Hagerstown, MD
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46290
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Indianapolis, IN
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Las Vegas, Nevada 89144
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McAllen, Texas 78503
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McAllen, TX
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Melbourne, Florida 32901
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Melbourne, FL
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Parramatta, New South Wales
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Parramatta,
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Pensacola, Florida 32503
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Phoenix, Arizona 85014
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Rapid City, South Dakota 57701
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Redlands, California 92374
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Reno, Nevada 89502
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Reno, NV
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Sacramento, California 95819
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Saint Petersburg, Florida 33703
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San Antonio, Texas 78240
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Santa Ana, California 92705
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Santa Ana, CA
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West Columbia, South Carolina 29169
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Wichita, Kansas 67214
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Wichita, KS
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Willow Park, Texas 76087
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Youngstown, Ohio 92705
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Youngstown, OH
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