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
sites
Cincinnati, Ohio 45242
98
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Cincinnati, OH
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1070
mi
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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
1960
mi
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Arcadia, CA
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Arlington, Texas 76012
928
mi
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Arlington, TX
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Augusta, Georgia 30909
451
mi
from 43215
Augusta, GA
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Austin, Texas 78705
1064
mi
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Austin, TX
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Austin, Texas 78705
1064
mi
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Austin, TX
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Bakersfield, California 93309
1983
mi
from 43215
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...
345
mi
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Baltimore, MD
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Beachwood, Ohio 44122
131
mi
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Beachwood, OH
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Bethlehem, Pennsylvania 18020
234
mi
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Bethlehem, PA
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Beverly Hills, California 90211
1979
mi
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Beverly Hills, CA
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Bloomfield, New Jersey 07003
468
mi
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Bloomfield, NJ
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50 Staniford Street
Boston, Massachusetts 02114
643
mi
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Boston, MA
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Colorado Springs, Colorado
1163
mi
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Colorado Springs, CO
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5 West Sample Road
Deerfield Beach, Florida 33064
960
mi
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Deerfield Beach, FL
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98 James Street
Edison, New Jersey 08820
458
mi
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Edison, NJ
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Edmond, Oklahoma 73013
844
mi
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Edmond, OK
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1101 6th Avenue
Fort Worth, Texas 76104
938
mi
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Fort Worth, TX
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Fullerton, California 92835
1959
mi
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Fullerton, CA
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Golden, Colorado 80401
1174
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Golden, CO
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Hagerstown, Maryland 21740
282
mi
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Hagerstown, MD
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Harlingen, Texas 78550
1270
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Harlingen, TX
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Houston, Texas 77025
991
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Houston, TX
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Houston, Texas 77030
995
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Houston, TX
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Indianapolis, Indiana 46290
166
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Indianapolis, IN
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1116 West Ganson Street
Jackson, Michigan 49202
174
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Jackson, MI
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Lakeland, Florida 33805
822
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Lakeland, FL
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Lexington, Kentucky 40509
154
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Lexington, KY
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Marietta, Georgia 30060
423
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Marietta, GA
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McAllen, Texas 78503
1291
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McAllen, TX
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Middleburg Heights, Ohio 44130
115
mi
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Middleburg Heights, OH
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Nashville, Tennessee 37203
333
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Nashville, TN
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Northfield, New Jersey
452
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Northfield, NJ
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6320 West 159th Street
Oak Forest, Illinois 60452
273
mi
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Oak Forest, IL
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Oak Park, Illinois 60304
281
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Oak Park, IL
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Oceanside, California 92056
1949
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Oceanside, CA
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Palo Alto, California 94304
2101
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Palo Alto, CA
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Pensacola, Florida 32503
700
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Pensacola, FL
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Phoenix, Arizona 85014
1660
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Phoenix, AZ
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1662
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Phoenix, AZ
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Reno, Nevada 89502
1936
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Reno, NV
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San Antonio, Texas 78240
1138
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San Antonio, TX
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Santa Barbara, California 93103
2038
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Santa Barbara, CA
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Santa Maria, California 93454
2065
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Santa Maria, CA
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Shirley, New York 11967
537
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Shirley, NY
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Spokane, Washington 99204
1778
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Spokane, WA
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414
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Syracuse, NY
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The Woodlands, Texas 77384
971
mi
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The Woodlands, TX
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West Des Moines, Iowa 50266
572
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West Des Moines, IA
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Wichita, Kansas 67226
785
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Wichita, KS
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Youngstown, Ohio 44505
147
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Youngstown, OH
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