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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02050828
Other study ID # AKB-9778-CI-2003
Secondary ID
Status Completed
Phase Phase 2
First received January 29, 2014
Last updated March 15, 2017
Start date January 2014
Est. completion date May 2015

Study information

Verified date March 2017
Source Aerpio Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date May 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility The following is an abbreviated list of inclusion criteria:

- Adults between 18 to 80 years of age, inclusive

- Diagnosis of diabetes mellitus (type 1 or type 2)

- Decrease in vision in the study eye determined to be primarily the result of DME

- Definite retinal thickening due to diffuse DME involving the central macula in the study eye

- Central subfield thickness of at least 325 µm by sdOCT with presence of intraretinal fluid in the study eye

- ETDRS BCVA letter score = 76 and = 24 in the study eye

The following is an abbreviated list of exclusion criteria:

- Hemoglobin A1C (HbA1C) = 12.0% at Screening

- History of non infectious uveitis

- Decrease in visual acuity due to causes other than DME in the study eye

- History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):

1. Prior pars plana vitrectomy

2. Any ocular surgery within 3 months prior to Day 1

3. YAG capsulotomy within 3 months prior to Day 1

4. Panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study

5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1

6. Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AKB-9778

ranibizumab

Placebo

Sham


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aerpio Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST) Month 3
Secondary Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) Month 3
See also
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Completed NCT02633852 - Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen of Aflibercept (EYLEA) as a Second Line Treatment for Diabetic Macular Edema Phase 4
Completed NCT04857996 - Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD) Phase 2
Recruiting NCT05919693 - A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD) Phase 1/Phase 2
Completed NCT04739306 - Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema Phase 3
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Terminated NCT02080091 - Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies N/A
Terminated NCT04697758 - Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema Phase 1/Phase 2
Terminated NCT00936520 - SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy Phase 1
Not yet recruiting NCT06398080 - An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
Active, not recruiting NCT05989126 - Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS) Phase 3