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Diabetes MellitusPhase 2VIDINCT02302079

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

A Phase 2 study testing ASP8232 and ranibizumab in people with Diabetes Mellitus and Diabetic Macular Edema, run by Astellas Pharma Europe B.V. at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Diabetes Mellitus, Diabetic Macular Edema
What is being tested?
ASP8232 and ranibizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
21 sitesUnited States
Study dates
12 Jan 2015to 12 Aug 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Site US10010

    Abilene, Texas, 79606

  • Site US10006

    Arcadia, California, 91007

  • Site US10036

    Augusta, Georgia, 30909

  • Site US10015

    Austin, Texas, 78705

  • Site US10004

    Beverly Hills, California, 90211

  • Site US10002

    Boston, Massachusetts, 02114

  • Site US10017

    Charlottesville, Virginia, 22903

  • Site US10029

    Golden, Colorado, 80401

  • Site US10013

    Houston, Texas, 77030

  • Site US10030

    McAllen, Texas, 78503

  • Site US10016

    Miami, Florida, 33126

  • Site US10012

    Nashville, Tennessee, 37203

  • Site US10001

    Omaha, Nebraska, 985540

  • Site US10007

    Palm Desert, California, 92260

  • Site US10021

    Phoenix, Arizona, 85104

  • Site US10027

    Reno, Nevada, 89511

  • Site US10011

    Sacramento, California, 95819

  • Site US10009

    San Antonio, Texas, 78240-1502

  • Site US10031

    Santa Ana, California, 92705

  • Site US10025

    Tucson, Arizona, 85704

  • Site US10005

    Winter Haven, Florida, 33880

Other trials in United States

About this study

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

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.

Being tested
ASP8232, ranibizumab, Placebo, Sham intravitreal (IVT) injection
Keywords
ASP8232, Diabetes Mellitus, ranibizumab, Diabetic Macular Edema
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP8232Drug

    oral capsule

  • ranibizumabDrug

    Also called Lucentis

    intravitreal (IVT) injection

  • PlaceboDrug

    oral capsule

  • Sham intravitreal (IVT) injectionOther

    intravitreal (IVT) injection

Study groups in NCT02302079
Study groupRoleWhat they receive
ASP8232 + sham intravitreal (IVT) injectionsExperimentalASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
Receives: Drug: ASP8232; Other: Sham intravitreal (IVT) injection
ASP8232 + ranibizumab intravitreal (IVT) injectionsExperimentalASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Receives: Drug: ASP8232; Drug: ranibizumab
Placebo + ranibizumab intravitreal (IVT) injectionsActive comparatorPlacebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
Receives: Drug: ranibizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and Month 3

Secondary outcomes (3)

  1. Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3

    Measured: Baseline and Month 3

  2. Change from baseline in early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) score in the study eye at Month 3

    Measured: Baseline and Month 3

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

    Measured: Baseline and Months 1, 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2014 (estimated)
  2. Study start12 Jan 2015
  3. Primary completion12 Aug 2016
  4. Study completion12 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02302079
Sponsor's protocol ID
8232-CL-3001
Acronym
VIDI
Status last verified
Oct 2024
First submitted
24 Nov 2014
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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/.

Publications

  • 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.

    PubMed 31388454

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP8232 and ranibizumab in people with Diabetes Mellitus and Diabetic Macular Edema, run by Astellas Pharma Europe B.V. at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Baseline and Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02302079, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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