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

October 29, 2024 updated by: Astellas Pharma Europe B.V.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85104
        • Site US10021
      • Tucson, Arizona, United States, 85704
        • Site US10025
    • California
      • Arcadia, California, United States, 91007
        • Site US10006
      • Beverly Hills, California, United States, 90211
        • Site US10004
      • Palm Desert, California, United States, 92260
        • Site US10007
      • Sacramento, California, United States, 95819
        • Site US10011
      • Santa Ana, California, United States, 92705
        • Site US10031
    • Colorado
      • Golden, Colorado, United States, 80401
        • Site US10029
    • Florida
      • Miami, Florida, United States, 33126
        • Site US10016
      • Winter Haven, Florida, United States, 33880
        • Site US10005
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Site US10036
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Site US10002
    • Nebraska
      • Omaha, Nebraska, United States, 985540
        • Site US10001
    • Nevada
      • Reno, Nevada, United States, 89511
        • Site US10027
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Site US10012
    • Texas
      • Abilene, Texas, United States, 79606
        • Site US10010
      • Austin, Texas, United States, 78705
        • Site US10015
      • Houston, Texas, United States, 77030
        • Site US10013
      • McAllen, Texas, United States, 78503
        • Site US10030
      • San Antonio, Texas, United States, 78240-1502
        • Site US10009
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Site US10017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASP8232 + sham intravitreal (IVT) injections
ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
Drug: ASP8232
oral capsule
Other: Sham intravitreal (IVT) injection
intravitreal (IVT) injection
Experimental: ASP8232 + ranibizumab intravitreal (IVT) injections
ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Drug: ASP8232
oral capsule
Drug: ranibizumab
intravitreal (IVT) injection
Other Names:
  • Lucentis
Active Comparator: Placebo + ranibizumab intravitreal (IVT) injections
Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Drug: ranibizumab
intravitreal (IVT) injection
Other Names:
  • Lucentis
Drug: Placebo
oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and Months 1, 2
Baseline and Months 1, 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Investigators

  • Study Director: Global Medical Lead, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2015

Primary Completion (Actual)

August 12, 2016

Study Completion (Actual)

August 12, 2016

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimated)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8232-CL-3001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/.

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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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