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

Primary Purpose

Diabetes Mellitus, Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ASP8232
ranibizumab
Placebo
Sham intravitreal (IVT) injection
Sponsored by
Astellas Pharma Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring ASP8232, Diabetes Mellitus, ranibizumab, Diabetic Macular Edema

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Site US10021
  • Site US10025
  • Site US10006
  • Site US10004
  • Site US10007
  • Site US10011
  • Site US10031
  • Site US10029
  • Site US10016
  • Site US10005
  • Site US10036
  • Site US10002
  • Site US10001
  • Site US10027
  • Site US10012
  • Site US10010
  • Site US10015
  • Site US10013
  • Site US10030
  • Site US10009
  • Site US10017

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ASP8232 + sham intravitreal (IVT) injections

ASP8232 + ranibizumab intravitreal (IVT) injections

Placebo + ranibizumab intravitreal (IVT) injections

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Absolute change from baseline in CST in the study eye as assessed by SD-OCT at 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
Absolute and percent change from baseline in excess CST in the study eye as assessed by SD-OCT at Months 1 and 2

Full Information

First Posted
November 24, 2014
Last Updated
March 4, 2019
Sponsor
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT02302079
Brief Title
A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 12, 2015 (Actual)
Primary Completion Date
August 12, 2016 (Actual)
Study Completion Date
August 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Macular Edema
Keywords
ASP8232, Diabetes Mellitus, ranibizumab, Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP8232 + sham intravitreal (IVT) injections
Arm Type
Experimental
Arm Description
ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
Arm Title
ASP8232 + ranibizumab intravitreal (IVT) injections
Arm Type
Experimental
Arm Description
ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Arm Title
Placebo + ranibizumab intravitreal (IVT) injections
Arm Type
Active Comparator
Arm Description
Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Intervention Type
Drug
Intervention Name(s)
ASP8232
Intervention Description
oral capsule
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
intravitreal (IVT) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsule
Intervention Type
Other
Intervention Name(s)
Sham intravitreal (IVT) injection
Intervention Description
intravitreal (IVT) injection
Primary Outcome Measure Information:
Title
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
Time Frame
Baseline and Month 3
Secondary Outcome Measure Information:
Title
Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3
Time Frame
Baseline and Month 3
Title
Change from baseline in early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) score in the study eye at Month 3
Time Frame
Baseline and Month 3
Title
Absolute and percent change from baseline in excess CST in the study eye as assessed by SD-OCT at Months 1 and 2
Time Frame
Baseline and Months 1, 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Lead
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Site US10021
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85104
Country
United States
Facility Name
Site US10025
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Site US10006
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Site US10004
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Site US10007
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Site US10011
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Site US10031
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Site US10029
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Site US10016
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Site US10005
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Site US10036
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Site US10002
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Site US10001
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
985540
Country
United States
Facility Name
Site US10027
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Site US10012
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Site US10010
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Site US10015
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site US10013
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site US10030
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Site US10009
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1502
Country
United States
Facility Name
Site US10017
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
31388454
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=298
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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