Clinical trial NCT02302079: A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetic Macular Edema
Keywords: ASP8232
Diabetes Mellitus
ranibizumab
Diabetic Macular Edema
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-11-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline and Month 3
Secondary outcomes:
measure: Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3
timeFrame: Baseline and Month 3
measure: Change from baseline in early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) score in the study eye at Month 3
timeFrame: Baseline and Month 3
measure: Absolute and percent change from baseline in excess CST in the study eye as assessed by SD-OCT at Months 1 and 2
timeFrame: Baseline and Months 1, 2
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site US10021
state: Arizona
city: Tucson
country: United States
facility: Site US10025
state: Arizona
city: Arcadia
country: United States
facility: Site US10006
state: California
city: Beverly Hills
country: United States
facility: Site US10004
state: California
city: Palm Desert
country: United States
facility: Site US10007
state: California
city: Sacramento
country: United States
facility: Site US10011
state: California
city: Santa Ana
country: United States
facility: Site US10031
state: California
city: Golden
country: United States
facility: Site US10029
state: Colorado
city: Miami
country: United States
facility: Site US10016
state: Florida
city: Winter Haven
country: United States
facility: Site US10005
state: Florida
city: Augusta
country: United States
facility: Site US10036
state: Georgia
city: Boston
country: United States
facility: Site US10002
state: Massachusetts
city: Omaha
country: United States
facility: Site US10001
state: Nebraska
city: Reno
country: United States
facility: Site US10027
state: Nevada
city: Nashville
country: United States
facility: Site US10012
state: Tennessee
city: Abilene
country: United States
facility: Site US10010
state: Texas
city: Austin
country: United States
facility: Site US10015
state: Texas
city: Houston
country: United States
facility: Site US10013
state: Texas
city: McAllen
country: United States
facility: Site US10030
state: Texas
city: San Antonio
country: United States
facility: Site US10009
state: Texas
city: Charlottesville
country: United States
facility: Site US10017
state: Virginia
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Global Medical Lead
role: STUDY_DIRECTOR
References:
citation: Nguyen QD, Sepah YJ, Berger B, Brown D, Do DV, Garcia-Hernandez A, Patel S, Rahhal FM, Shildkrot Y, Renfurm RW; VIDI Research Group. Primary outcomes of the VIDI study: phase 2, double-masked, randomized, active-controlled study of ASP8232 for diabetic macular edema. Int J Retina Vitreous. 2019 Aug 1;5:28. doi: 10.1186/s40942-019-0178-7. eCollection 2019.