A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME)
VIDI
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
1 other identifier
interventional
96
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus
Started Jan 2015
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2014
CompletedFirst Posted
Study publicly available on registry
November 26, 2014
CompletedStudy Start
First participant enrolled
January 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2016
CompletedOctober 31, 2024
October 1, 2024
1.6 years
November 24, 2014
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3
Baseline and Month 3
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 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
Study Arms (3)
ASP8232 + sham intravitreal (IVT) injections
EXPERIMENTALASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
ASP8232 + ranibizumab intravitreal (IVT) injections
EXPERIMENTALASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Placebo + ranibizumab intravitreal (IVT) injections
ACTIVE COMPARATORPlacebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Interventions
oral capsule
intravitreal (IVT) injection
intravitreal (IVT) injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Site US10021
Phoenix, Arizona, 85104, United States
Site US10025
Tucson, Arizona, 85704, United States
Site US10006
Arcadia, California, 91007, United States
Site US10004
Beverly Hills, California, 90211, United States
Site US10007
Palm Desert, California, 92260, United States
Site US10011
Sacramento, California, 95819, United States
Site US10031
Santa Ana, California, 92705, United States
Site US10029
Golden, Colorado, 80401, United States
Site US10016
Miami, Florida, 33126, United States
Site US10005
Winter Haven, Florida, 33880, United States
Site US10036
Augusta, Georgia, 30909, United States
Site US10002
Boston, Massachusetts, 02114, United States
Site US10001
Omaha, Nebraska, 985540, United States
Site US10027
Reno, Nevada, 89511, United States
Site US10012
Nashville, Tennessee, 37203, United States
Site US10010
Abilene, Texas, 79606, United States
Site US10015
Austin, Texas, 78705, United States
Site US10013
Houston, Texas, 77030, United States
Site US10030
McAllen, Texas, 78503, United States
Site US10009
San Antonio, Texas, 78240-1502, United States
Site US10017
Charlottesville, Virginia, 22903, United States
Related Publications (1)
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.
PMID: 31388454DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Medical Lead
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2014
First Posted
November 26, 2014
Study Start
January 12, 2015
Primary Completion
August 12, 2016
Study Completion
August 12, 2016
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.