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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Trial Summary
Trial Overview
Inclusion Criteria

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