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

Sponsor

Aerpio Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03197870

Collaborator

(none)

167

Enrollment

Locations

Arms

Actual Duration (Months)

3.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Nonproliferative Diabetic Retinopathy	Drug: AKB-9778 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 9, 2017

Actual Primary Completion Date :

Jan 9, 2019

Actual Study Completion Date :

Feb 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AKB-9778 15mg BID	Drug: AKB-9778 Subcutaneous AKB-9778 15mg
Experimental: AKB-9778 15mg QD	Drug: AKB-9778 Subcutaneous AKB-9778 15mg Drug: Placebo Subcutaneous Placebo
Placebo Comparator: Placebo BID	Drug: Placebo Subcutaneous Placebo

Arm

Intervention/Treatment

Experimental: AKB-9778 15mg BID

Drug: AKB-9778

Subcutaneous AKB-9778 15mg

Experimental: AKB-9778 15mg QD

Drug: AKB-9778

Subcutaneous AKB-9778 15mg

Drug: Placebo

Subcutaneous Placebo

Placebo Comparator: Placebo BID

Drug: Placebo

Subcutaneous Placebo

Outcome Measures

Primary Outcome Measures

Percentage of subjects with an improvement in study eye severity of diabetic retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 steps [Baseline to Week 48]

Secondary Outcome Measures

Secondary outcomes include improvement of DRSS and worsening of DRSS in the study eye, the fellow eye, and both eyes [Baseline to Week 48]
Incidence and severity of adverse events [Baseline to Week 48]
Change from baseline in clinical laboratory assay results [Baseline to Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Retina and Vitreous Consultants	Phoenix	Arizona	United States	85021
2	Retinal Research Institute	Phoenix	Arizona	United States	85053
3	Retina Institute of California	Arcadia	California	United States	91007
4	California Retina Consultants	Bakersfield	California	United States	93309
5	Retina Vitreous Associates Medical Group	Beverly Hills	California	United States	90211
6	Retina Consultants of Orange County	Fullerton	California	United States	92835
7	Ophthalmic Clinical Trials San Diego	Oceanside	California	United States	92056
8	Stanford	Palo Alto	California	United States	94303
9	California Retina Consultants	Santa Barbara	California	United States	93103
10	California Retina Consultants	Santa Maria	California	United States	93454
11	Retina Consultants of Southern Colorado	Colorado Springs	Colorado	United States	80909
12	Colorado Retina Associates	Golden	Colorado	United States	80401
13	Rand Eye Institute	Deerfield Beach	Florida	United States	33064
14	Center for Retina and Macular Disease	Lakeland	Florida	United States	33805
15	Retina Specialty Institute	Pensacola	Florida	United States	32503
16	Southeast Retina Center	Augusta	Georgia	United States	30909
17	Georgia Retina	Marietta	Georgia	United States	30060
18	University Retina	Oak Forest	Illinois	United States	60452
19	Illinois Retina Associates	Oak Park	Illinois	United States	60304
20	Midwest Eye Institute	Indianapolis	Indiana	United States	46290
21	Wolfe Eye Clinic	West Des Moines	Iowa	United States	50266
22	Central Plains Eye MDs	Wichita	Kansas	United States	67226
23	Retina Associates of Kentucky	Lexington	Kentucky	United States	40509
24	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	212876
25	Cumberland Valley Retina Consultants PC	Hagerstown	Maryland	United States	21740
26	Opthalmic Consultants of Boston	Boston	Massachusetts	United States	02114
27	Specialty Eye Institute	Jackson	Michigan	United States	49202
28	Sierra Eye Associates	Reno	Nevada	United States	89502
29	Retina Center of New Jersey	Bloomfield	New Jersey	United States	07003
30	New Jersey Retina	Edison	New Jersey	United States	08820
31	Retinal and Ophthalmic Consultants P.C.	Northfield	New Jersey	United States	08225
32	Eye Associates of New Mexico	Albuquerque	New Mexico	United States	87109
33	Island Retina	Shirley	New York	United States	11967
34	Retina Vitreous Surgeons of Central New York	Syracuse	New York	United States	13224
35	Retina Associates of Cleveland	Beachwood	Ohio	United States	44122
36	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
37	Retina Associates of Cleveland	Middleburg Heights	Ohio	United States	44130
38	Retina Associates of Cleveland	Youngstown	Ohio	United States	44505
39	Retina Vitreous Center	Edmond	Oklahoma	United States	73013
40	Mid-Atlantic Retina	Bethlehem	Pennsylvania	United States	18017
41	Tennessee Retina	Nashville	Tennessee	United States	37203
42	Retina Research Institute of Texas	Abilene	Texas	United States	79606
43	Texas Retina Associates	Arlington	Texas	United States	76012
44	Austin Retina Associates	Austin	Texas	United States	78705
45	Retina Research Center	Austin	Texas	United States	78705
46	Texas Retina Associates	Fort Worth	Texas	United States	76104
47	Valley Retina Institute	Harlingen	Texas	United States	78550
48	Retina and Vitreous of Texas	Houston	Texas	United States	77025
49	Retina Consultants of Houston	Houston	Texas	United States	77030
50	Valley Retina Institute	McAllen	Texas	United States	78503
51	Medical Center Ophthalmology Associates	San Antonio	Texas	United States	78240
52	Retina Consultants of Houston	The Woodlands	Texas	United States	77384
53	Spokane Eye Clinical Research	Spokane	Washington	United States	99204

Sponsors and Collaborators

Aerpio Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aerpio Therapeutics

ClinicalTrials.gov Identifier:

NCT03197870

Other Study ID Numbers:

AKB-9778-CI-5001

First Posted:

Jun 23, 2017

Last Update Posted:

Jul 31, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Study Results

No Results Posted as of Jul 31, 2019