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

Diabetes Mellitus Clinical Trial

— VIDI  

Official title:

A Phase 2, Double-Masked, Randomized, Active Controlled Study to Evaluate the Efficacy and Safety of ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302079
• Other study ID #: 8232-CL-3001
• Status: Completed
• Phase: Phase 2
• Start date: January 12, 2015
• Est. completion date: August 12, 2016

Study information

• Verified date: March 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 12, 2016
• Est. primary completion date: August 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• ASP8232
oral capsule
• ranibizumab
intravitreal (IVT) injection
• Placebo
oral capsule

Other:
• Sham intravitreal (IVT) injection
intravitreal (IVT) injection

Locations

Country	Name	City	State
United States	Site US10010	Abilene	Texas
United States	Site US10006	Arcadia	California
United States	Site US10036	Augusta	Georgia
United States	Site US10015	Austin	Texas
United States	Site US10004	Beverly Hills	California
United States	Site US10002	Boston	Massachusetts
United States	Site US10017	Charlottesville	Virginia
United States	Site US10029	Golden	Colorado
United States	Site US10013	Houston	Texas
United States	Site US10030	McAllen	Texas
United States	Site US10016	Miami	Florida
United States	Site US10012	Nashville	Tennessee
United States	Site US10001	Omaha	Nebraska
United States	Site US10007	Palm Desert	California
United States	Site US10021	Phoenix	Arizona
United States	Site US10027	Reno	Nevada
United States	Site US10011	Sacramento	California
United States	Site US10009	San Antonio	Texas
United States	Site US10031	Santa Ana	California
United States	Site US10025	Tucson	Arizona
United States	Site US10005	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3		Baseline and Month 3
Secondary	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
Secondary	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

External Links

•   Link to results on the Astellas Clinical Study Results website