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

Astellas

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema; Diabetes Mellitus

Treatments: Drug: ASP8232; Drug: ranibizumab; Other: Sham intravitreal (IVT) injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02302079

8232-CL-3001

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 3 patient groups

ASP8232 + sham intravitreal (IVT) injections

Experimental group

Description:

ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals

Treatment:

Other: Sham intravitreal (IVT) injection

Drug: ASP8232

ASP8232 + ranibizumab intravitreal (IVT) injections

Experimental group

Description:

ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals

Treatment:

Drug: ranibizumab

Drug: ASP8232

Placebo + ranibizumab intravitreal (IVT) injections

Active Comparator group

Description:

Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals

Treatment:

Drug: Placebo

Drug: ranibizumab