The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema

Part of paid clinical trials in Pheonix, Arizona.

Sponsor
Aerpio Therapeutics
Study ID
NCT02050828
Phase
PHASE2
Status
Completed

Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AKB-9778 — DRUG
  • ranibizumab — DRUG
  • Placebo — DRUG
  • Sham — DRUG

Study Details

The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with diabetic macular edema.

Key Dates

First listed
Jan 31, 2014
Start date
Jan 31, 2014
Status verified
Mar 2017
Primary completion
Apr 30, 2015
Completion
May 31, 2015

Study Design

Enrollment
144 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AKB-9778 15 mg BID monotherapy
    Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
  • Experimental: AKB-9778 15 mg BID + ranibizumab 0.3 mg
    Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
  • Active Comparator: ranibizumab 0.3 mg monotherapy
    Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.

Primary Outcome Measure

Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST) [ Time Frame: Month 3 ]

Locations (39)

FacilityCityStateZIPSite coordinators
-PheonixArizona85014-
-PheonixArizona85020-
-TucsonArizona85704-
-ArcadiaCalifornia91007-
-BakersfieldCalifornia93309-
-Beverly HillsCalifornia90211-
-Palm DesertCalifornia92260-
-SacramentoCalifornia95819-
-Santa AnaCalifornia92705-
-Santa BarbaraCalifornia93103-
-GoldenColorado80401-
-Boynton BeachFlorida33426-
-Fort LauderdaleFlorida33334-
-Fort MyersFlorida33912-
-MiamiFlorida33126-
-SarasotaFlorida34239-
-StuartFlorida34994-
-Winter HavenFlorida33880-
-BaltimoreMaryland21287-
-JacksonMichigan49202-
-OmahaNebraska68198-
-RenoNevada89502-
-RochesterNew York14620-
-CharlotteNorth Carolina28210-
-CincinnatiOhio45242-
-ClevelandOhio44195-
-PortlandOregon97210-
-FlorenceSouth Carolina29501-
-Rapid CitySouth Dakota57701-
-NashvilleTennessee37203-
-AbileneTexas79606-
-AustinTexas78705-
-Fort WorthTexas76102-
-HoustonTexas77030-
-McAllenTexas78503-
-San AntonioTexas78240-
-Salt Lake CityUtah84107-
-WarrentonVirginia20186-
-BellevueWashington98004-

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