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
364
mi
from 91732
Sacramento, CA
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Abilene, Texas 79606
1060
mi
from 91732
Abilene, TX
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Arlington, Texas 76012
?
mi
from 91732
Arlington, TX
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Asheville, North Carolina 28803
2003
mi
from 91732
Asheville, NC
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Augusta, Georgia 30909
2053
mi
from 91732
Augusta, GA
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Austin, Texas 78705
1211
mi
from 91732
Austin, TX
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Bakersfield, California 93309
106
mi
from 91732
Bakersfield, CA
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Beverly Hills, California 90211
21
mi
from 91732
Beverly Hills, CA
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Boynton Beach, Florida 33426
2307
mi
from 91732
Boynton Beach, FL
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Charleston, South Carolina 29414
2175
mi
from 91732
Charleston, SC
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Charlotte, North Carolina 28210
2101
mi
from 91732
Charlotte, NC
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Colorado Springs, Colorado 80909
805
mi
from 91732
Colorado Springs, CO
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Des Moines, Iowa 50266
?
mi
from 91732
Des Moines, IA
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Fort Myers, Florida 33912
2205
mi
from 91732
Fort Myers, FL
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Germantown, Tennessee 38138
?
mi
from 91732
Germantown, TN
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Hagerstown, Maryland 21740
?
mi
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Hagerstown, MD
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Indianapolis, Indiana 46290
?
mi
from 91732
Indianapolis, IN
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Las Vegas, Nevada 89144
210
mi
from 91732
Las Vegas, NV
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McAllen, Texas 78503
?
mi
from 91732
McAllen, TX
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Melbourne, Florida 32901
2238
mi
from 91732
Melbourne, FL
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Parramatta, New South Wales
?
mi
from 91732
Parramatta,
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Pensacola, Florida 32503
1809
mi
from 91732
Pensacola, FL
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Phoenix, Arizona 85014
344
mi
from 91732
Phoenix, AZ
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Portland, Oregon 97239
828
mi
from 91732
Portland, OR
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Rapid City, South Dakota 57701
?
mi
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Rapid City, SD
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Redlands, California 92374
49
mi
from 91732
Redlands, CA
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Reno, Nevada 89502
385
mi
from 91732
Reno, NV
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Saint Petersburg, Florida 33703
2130
mi
from 91732
Saint Petersburg, FL
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San Antonio, Texas 78240
1179
mi
from 91732
San Antonio, TX
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Santa Ana, California 92705
78
mi
from 91732
Santa Ana, CA
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West Columbia, South Carolina 29169
2103
mi
from 91732
West Columbia, SC
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Wichita, Kansas 67214
1182
mi
from 91732
Wichita, KS
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Willow Park, Texas 76087
1355
mi
from 91732
Willow Park, TX
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Youngstown, Ohio 92705
?
mi
from 91732
Youngstown, OH
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