A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME)

Phase 2

Completed

• Conditions: Diabetes Mellitus; Diabetic Macular Edema
• Interventions: Drug: ASP8232; Drug: ranibizumab; Drug: Placebo; Other: Sham intravitreal (IVT) injection

• Registration Number: NCT02302079
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with diabetic macular edema (DME). This study will evaluate the percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-26
• Study Start: 2015-01-12
• Primary Completion: 2016-08-12
• Study Completion: 2016-08-12
• Disposition First Submitted: 2017-08-01
• Disposition First Submitted QC: 2017-08-01
• Disposition First Posted: 2017-08-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Subject must have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% at Screening
• Subject has definite retinal thickening due to diffuse diabetic macular edema (DME) involving the central macula based on evaluating investigator's clinical evaluation and demonstrated by spectral domain-optical coherence tomography (SD-OCT)
• Subject has central subfield thickness (CST) of at least 375 μm by SD-OCT with presence of intraretinal and/or subretinal fluid at screening visit and at the randomization visit
• Subject has early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit

Exclusion Criteria

• Subject's study eye has macular edema considered to be due to a cause other than DME
• Subject's study eye has a decrease in BCVA due to causes other than DME that is likely to be decreasing BCVA by 3 lines or more
• Subject's study eye has significant macular ischemia as shown on angiography
• Subject's study eye has any other ocular disease that may cause substantial reduction in BCVA
• Subject has active peri-ocular or ocular infection
• Subject's study eye has a history of non-infectious uveitis
• Subject's study eye has high myopia (-8 diopter or more correction)
• Subject's study eye has a history of prior pars plana vitrectomy
• Subject's study eye has a history of any ocular surgery within 3 months prior to Day 1
• Subject's study eye has a history of YAG capsulotomy within 3 months prior to Day 1
• Subject's study eye has a history of 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 through the Week 12 visit
• Subject's study eye has a history of prior IVT, subtenon, or periocular, non-sustained release, steroid therapy within 3 months prior to Day 1
• Subject's study eye has a history of intravitreal sustained release dexamethasone therapy within 6 months prior to Day 1.
• Subject's study eye has a history of intravitreal sustained release fluocinolone within 3 years prior to Day 1.
• Subject's study eye has a history of prior treatment for DME with IVT anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1
• Subject has a history of prior treatment with any other (than previously listed) approved treatment which is not labeled for DME within 1 year prior to Day 1
• Subject's study eye has high-risk proliferative diabetic retinopathy (PDR)
• Subject has uncontrolled glaucoma
• Subject has media clarity, papillary constriction (i.e., senile miosis), or subject lacks cooperation that would interfere with any study procedures, evaluations or interpretation of data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + ranibizumab intravitreal (IVT) injections	Placebo	Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
ASP8232 + sham intravitreal (IVT) injections	Sham intravitreal (IVT) injection	ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
ASP8232 + ranibizumab intravitreal (IVT) injections	ASP8232	ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Placebo + ranibizumab intravitreal (IVT) injections	ranibizumab	Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
ASP8232 + sham intravitreal (IVT) injections	ASP8232	ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
ASP8232 + ranibizumab intravitreal (IVT) injections	ranibizumab	ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence tomography (SD-OCT) at Month 3	Baseline and Month 3

Secondary Outcome Measures

Name	Time	Method
Absolute and percent change from baseline in excess CST in the study eye as assessed by SD-OCT at Months 1 and 2	Baseline and Months 1, 2
Change from baseline in early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) score in the study eye at Month 3	Baseline and Month 3
Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3	Baseline and Month 3

Trial Locations

Locations (21)

Site US10021; 🇺🇸 Phoenix, Arizona, United States

Site US10004; 🇺🇸 Beverly Hills, California, United States

Site US10030; 🇺🇸 McAllen, Texas, United States

Site US10011; 🇺🇸 Sacramento, California, United States

Site US10015; 🇺🇸 Austin, Texas, United States

Site US10007; 🇺🇸 Palm Desert, California, United States

Site US10029; 🇺🇸 Golden, Colorado, United States

Site US10005; 🇺🇸 Winter Haven, Florida, United States

Site US10036; 🇺🇸 Augusta, Georgia, United States

Site US10027; 🇺🇸 Reno, Nevada, United States

Site US10006; 🇺🇸 Arcadia, California, United States

Site US10031; 🇺🇸 Santa Ana, California, United States

Site US10010; 🇺🇸 Abilene, Texas, United States

Site US10001; 🇺🇸 Omaha, Nebraska, United States

Site US10016; 🇺🇸 Miami, Florida, United States

Site US10002; 🇺🇸 Boston, Massachusetts, United States

Site US10012; 🇺🇸 Nashville, Tennessee, United States

Site US10013; 🇺🇸 Houston, Texas, United States

Site US10009; 🇺🇸 San Antonio, Texas, United States

Site US10025; 🇺🇸 Tucson, Arizona, United States

Site US10017; 🇺🇸 Charlottesville, Virginia, United States