A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME)
NCT ID: NCT02302079
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2015-01-12
2016-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ASP8232 + sham intravitreal (IVT) injections
ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
ASP8232
oral capsule
Sham intravitreal (IVT) injection
intravitreal (IVT) injection
ASP8232 + ranibizumab intravitreal (IVT) injections
ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
ASP8232
oral capsule
ranibizumab
intravitreal (IVT) injection
Placebo + ranibizumab intravitreal (IVT) injections
Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
ranibizumab
intravitreal (IVT) injection
Placebo
oral capsule
Interventions
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ASP8232
oral capsule
ranibizumab
intravitreal (IVT) injection
Placebo
oral capsule
Sham intravitreal (IVT) injection
intravitreal (IVT) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Medical Lead
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site US10021
Phoenix, Arizona, United States
Site US10025
Tucson, Arizona, United States
Site US10006
Arcadia, California, United States
Site US10004
Beverly Hills, California, United States
Site US10007
Palm Desert, California, United States
Site US10011
Sacramento, California, United States
Site US10031
Santa Ana, California, United States
Site US10029
Golden, Colorado, United States
Site US10016
Miami, Florida, United States
Site US10005
Winter Haven, Florida, United States
Site US10036
Augusta, Georgia, United States
Site US10002
Boston, Massachusetts, United States
Site US10001
Omaha, Nebraska, United States
Site US10027
Reno, Nevada, United States
Site US10012
Nashville, Tennessee, United States
Site US10010
Abilene, Texas, United States
Site US10015
Austin, Texas, United States
Site US10013
Houston, Texas, United States
Site US10030
McAllen, Texas, United States
Site US10009
San Antonio, Texas, United States
Site US10017
Charlottesville, Virginia, United States
Countries
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References
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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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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8232-CL-3001
Identifier Type: -
Identifier Source: org_study_id
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