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

Use our guide to learn which trials are right for you!

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