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
Bakersfield, California 93309
2590
mi
from 02139
Bakersfield, CA
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Abilene, Texas 79606
1703
mi
from 02139
Abilene, TX
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Arlington, Texas 76012
?
mi
from 02139
Arlington, TX
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Asheville, North Carolina 28803
772
mi
from 02139
Asheville, NC
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Augusta, Georgia 30909
856
mi
from 02139
Augusta, GA
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Austin, Texas 78705
1690
mi
from 02139
Austin, TX
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Beverly Hills, California 90211
2595
mi
from 02139
Beverly Hills, CA
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Boynton Beach, Florida 33426
1206
mi
from 02139
Boynton Beach, FL
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Charleston, South Carolina 29414
820
mi
from 02139
Charleston, SC
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Charlotte, North Carolina 28210
724
mi
from 02139
Charlotte, NC
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Colorado Springs, Colorado 80909
1771
mi
from 02139
Colorado Springs, CO
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Des Moines, Iowa 50266
?
mi
from 02139
Des Moines, IA
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Fort Myers, Florida 33912
1245
mi
from 02139
Fort Myers, FL
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Germantown, Tennessee 38138
?
mi
from 02139
Germantown, TN
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Hagerstown, Maryland 21740
?
mi
from 02139
Hagerstown, MD
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Houston, Texas 77030
1605
mi
from 02139
Houston, TX
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Indianapolis, Indiana 46290
?
mi
from 02139
Indianapolis, IN
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Las Vegas, Nevada 89144
2375
mi
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Las Vegas, NV
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McAllen, Texas 78503
?
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McAllen, TX
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Melbourne, Florida 32901
1123
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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
1212
mi
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Pensacola, FL
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Phoenix, Arizona 85014
2290
mi
from 02139
Phoenix, AZ
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Portland, Oregon 97239
2530
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Portland, OR
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Rapid City, South Dakota 57701
?
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Rapid City, SD
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Redlands, California 92374
2532
mi
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Redlands, CA
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Reno, Nevada 89502
2511
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Reno, NV
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Sacramento, California 95819
2620
mi
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Sacramento, CA
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Saint Petersburg, Florida 33703
1195
mi
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Saint Petersburg, FL
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San Antonio, Texas 78240
1764
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San Antonio, TX
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Santa Ana, California 92705
2632
mi
from 02139
Santa Ana, CA
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West Columbia, South Carolina 29169
791
mi
from 02139
West Columbia, SC
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Wichita, Kansas 67214
1417
mi
from 02139
Wichita, KS
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Willow Park, Texas 76087
1610
mi
from 02139
Willow Park, TX
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Youngstown, Ohio 92705
?
mi
from 02139
Youngstown, OH
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