Diabetic Macular Edema (DME) Clinical Trial
— TIME-2Official title:
A Phase 2, Randomized, Active-Controlled, Double-Masked, Multi-Center Study to Assess the Safety and Efficacy of Daily Subcutaneous AKB-9778 Administered for 3 Months, as Monotherapy or Adjunctive to Ranibizumab, in Subjects With Diabetic Macular Edema
Verified date | March 2017 |
Source | Aerpio Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aerpio Therapeutics |
United States,
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 |
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