The TIME-2b Study: A Study of AKB-9778, a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)



Status:Active, not recruiting
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - 80
Updated:2/14/2018
Start Date:June 29, 2017
End Date:June 2019

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Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy

The purpose of this study is to evaluate the safety and efficacy of subcutaneously
administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with
moderate to severe non-proliferative diabetic retinopathy (NPDR).


Key Inclusion Criteria:

- Adults 18 through 80 years of age (inclusive)

- Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)

- No evidence of central involved DME

- ETDRS BCVA letter score ≥ 70 (Snellen 20/40 or better)

Key Exclusion Criteria:

- Ocular disease other than DR that may cause substantial reduction in visual acuity,
including iris neovascularization, retinal detachment, visually significant epiretinal
membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other
retinal inflammatory or infectious diseases

- Evidence of neovascularization on clinical examination or imaging

- Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening

- Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation
We found this trial at
53
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Cincinnati, Ohio 45242
726
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Cincinnati, OH
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388
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Abilene, TX
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Albuquerque, New Mexico 87109
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Albuquerque, NM
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Arcadia, California 91007
1156
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Arlington, Texas 76012
347
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Arlington, TX
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Augusta, Georgia 30909
936
mi
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Augusta, GA
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Austin, Texas 78705
515
mi
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Austin, TX
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Austin, Texas 78705
515
mi
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Austin, TX
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Bakersfield, California 93309
1188
mi
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Bakersfield, CA
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
1149
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Baltimore, MD
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Beachwood, Ohio 44122
904
mi
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Beachwood, OH
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Bethlehem, Pennsylvania 18020
1040
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Bethlehem, PA
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Beverly Hills, California 90211
1175
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Beverly Hills, CA
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Bloomfield, New Jersey 07003
1277
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Bloomfield, NJ
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50 Staniford Street
Boston, Massachusetts 02114
1443
mi
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Boston, MA
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Colorado Springs, Colorado
386
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Colorado Springs, CO
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5 West Sample Road
Deerfield Beach, Florida 33064
1301
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Deerfield Beach, FL
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98 James Street
Edison, New Jersey 08820
1268
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Edison, NJ
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Edmond, Oklahoma 73013
147
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Edmond, OK
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1101 6th Avenue
Fort Worth, Texas 76104
347
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Fort Worth, TX
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Fullerton, California 92835
1154
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Fullerton, CA
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Golden, Colorado 80401
422
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Golden, CO
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Hagerstown, Maryland 21740
1089
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Hagerstown, MD
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Harlingen, Texas 78550
797
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Harlingen, TX
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Houston, Texas 77025
569
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Houston, TX
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Houston, Texas 77030
572
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Houston, TX
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Indianapolis, Indiana 46290
643
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Indianapolis, IN
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1116 West Ganson Street
Jackson, Michigan 49202
773
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Jackson, MI
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Lakeland, Florida 33805
1135
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Lakeland, FL
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Lexington, Kentucky 40509
731
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Lexington, KY
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Marietta, Georgia 30060
787
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Marietta, GA
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McAllen, Texas 78503
797
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McAllen, TX
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Middleburg Heights, Ohio 44130
887
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Middleburg Heights, OH
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Nashville, Tennessee 37203
618
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Nashville, TN
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Northfield, New Jersey
1258
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Northfield, NJ
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6320 West 159th Street
Oak Forest, Illinois 60452
596
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Oak Forest, IL
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Oak Park, Illinois 60304
603
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Oak Park, IL
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Oceanside, California 92056
1142
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Oceanside, CA
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Palo Alto, California 94304
1329
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Pensacola, Florida 32503
789
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Phoenix, Arizona 85014
850
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Phoenix, AZ
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852
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Phoenix, AZ
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Reno, Nevada 89502
1185
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Reno, NV
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San Antonio, Texas 78240
576
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San Antonio, TX
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Santa Barbara, California 93103
1238
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Santa Barbara, CA
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Santa Maria, California 93454
1269
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Santa Maria, CA
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Shirley, New York 11967
1346
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Shirley, NY
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Spokane, Washington 99204
1201
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Spokane, WA
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1193
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Syracuse, NY
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The Woodlands, Texas 77384
535
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The Woodlands, TX
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West Des Moines, Iowa 50266
340
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West Des Moines, IA
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Wichita, Kansas 67226
26
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Wichita, KS
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Youngstown, Ohio 44505
943
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Youngstown, OH
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