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
Sacramento, California 95819
2041
mi
from 43215
Sacramento, CA
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Abilene, Texas 79606
1063
mi
from 43215
Abilene, TX
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Arlington, Texas 76012
?
mi
from 43215
Arlington, TX
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Asheville, North Carolina 28803
304
mi
from 43215
Asheville, NC
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Augusta, Georgia 30909
452
mi
from 43215
Augusta, GA
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Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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Bakersfield, California 93309
1982
mi
from 43215
Bakersfield, CA
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Beverly Hills, California 90211
1979
mi
from 43215
Beverly Hills, CA
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Boynton Beach, Florida 33426
943
mi
from 43215
Boynton Beach, FL
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Charleston, South Carolina 29414
519
mi
from 43215
Charleston, SC
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Charlotte, North Carolina 28210
354
mi
from 43215
Charlotte, NC
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Colorado Springs, Colorado 80909
1161
mi
from 43215
Colorado Springs, CO
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Des Moines, Iowa 50266
?
mi
from 43215
Des Moines, IA
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Fort Myers, Florida 33912
924
mi
from 43215
Fort Myers, FL
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Germantown, Tennessee 38138
?
mi
from 43215
Germantown, TN
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Hagerstown, Maryland 21740
?
mi
from 43215
Hagerstown, MD
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Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Indianapolis, Indiana 46290
?
mi
from 43215
Indianapolis, IN
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Las Vegas, Nevada 89144
1765
mi
from 43215
Las Vegas, NV
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McAllen, Texas 78503
?
mi
from 43215
McAllen, TX
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Melbourne, Florida 32901
833
mi
from 43215
Melbourne, FL
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Parramatta, New South Wales
?
mi
from 43215
Parramatta,
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Pensacola, Florida 32503
697
mi
from 43215
Pensacola, FL
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Phoenix, Arizona 85014
1660
mi
from 43215
Phoenix, AZ
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Portland, Oregon 97239
2026
mi
from 43215
Portland, OR
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Rapid City, South Dakota 57701
?
mi
from 43215
Rapid City, SD
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Redlands, California 92374
1914
mi
from 43215
Redlands, CA
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Reno, Nevada 89502
1936
mi
from 43215
Reno, NV
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Saint Petersburg, Florida 33703
839
mi
from 43215
Saint Petersburg, FL
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San Antonio, Texas 78240
1138
mi
from 43215
San Antonio, TX
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Santa Ana, California 92705
2020
mi
from 43215
Santa Ana, CA
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West Columbia, South Carolina 29169
426
mi
from 43215
West Columbia, SC
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Wichita, Kansas 67214
783
mi
from 43215
Wichita, KS
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Willow Park, Texas 76087
999
mi
from 43215
Willow Park, TX
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Youngstown, Ohio 92705
?
mi
from 43215
Youngstown, OH
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