## Protocol Section
### Identification Module
**NCT ID:** NCT02302079

**Acronym:** VIDI

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

**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

#### Organization Study ID Info
**ID:** 8232-CL-3001
#### Organization
**Class:** INDUSTRY
**Full Name:** Astellas Pharma Inc
### Status Module
#### Completion Date
**Date:** 2016-08-12

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2017-08-08

**Type:** ACTUAL

**Disp First Submit Date:** 2017-08-01
**Disp First Submit QC Date:** 2017-08-01

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-06

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-08-12

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01-12

**Type:** ACTUAL

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2014-11-26
**Type:** ESTIMATED
**Study First Submit Date:** 2014-11-24
**Study First Submit QC Date:** 2014-11-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Astellas Pharma Europe B.V.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diabetes Mellitus

- Diabetic Macular Edema

**Keywords:**

- ASP8232

- Diabetes Mellitus

- ranibizumab

- Diabetic Macular Edema

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 96

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: ASP8232

- Other: Sham intravitreal (IVT) injection

**Label:** ASP8232 + sham intravitreal (IVT) injections

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: ASP8232

- Drug: ranibizumab

**Label:** ASP8232 + ranibizumab intravitreal (IVT) injections

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Drug: ranibizumab

- Drug: Placebo

**Label:** Placebo + ranibizumab intravitreal (IVT) injections

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ASP8232 + ranibizumab intravitreal (IVT) injections

- ASP8232 + sham intravitreal (IVT) injections

**Description:** oral capsule

**Name:** ASP8232

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- ASP8232 + ranibizumab intravitreal (IVT) injections

- Placebo + ranibizumab intravitreal (IVT) injections

**Description:** intravitreal (IVT) injection

**Name:** ranibizumab

**Other Names:**

- Lucentis

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo + ranibizumab intravitreal (IVT) injections

**Description:** oral capsule

**Name:** Placebo

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- ASP8232 + sham intravitreal (IVT) injections

**Description:** intravitreal (IVT) injection

**Name:** Sham intravitreal (IVT) injection

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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

#### Secondary Outcomes

**Measure:** Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3

**Time Frame:** Baseline and Month 3

**Measure:** 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

**Measure:** 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

### Eligibility Module

**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

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** Site US10021

**State:** Arizona

**Zip:** 85104

**Location 2:**

**City:** Tucson

**Country:** United States

**Facility:** Site US10025

**State:** Arizona

**Zip:** 85704

**Location 3:**

**City:** Arcadia

**Country:** United States

**Facility:** Site US10006

**State:** California

**Zip:** 91007

**Location 4:**

**City:** Beverly Hills

**Country:** United States

**Facility:** Site US10004

**State:** California

**Zip:** 90211

**Location 5:**

**City:** Palm Desert

**Country:** United States

**Facility:** Site US10007

**State:** California

**Zip:** 92260

**Location 6:**

**City:** Sacramento

**Country:** United States

**Facility:** Site US10011

**State:** California

**Zip:** 95819

**Location 7:**

**City:** Santa Ana

**Country:** United States

**Facility:** Site US10031

**State:** California

**Zip:** 92705

**Location 8:**

**City:** Golden

**Country:** United States

**Facility:** Site US10029

**State:** Colorado

**Zip:** 80401

**Location 9:**

**City:** Miami

**Country:** United States

**Facility:** Site US10016

**State:** Florida

**Zip:** 33126

**Location 10:**

**City:** Winter Haven

**Country:** United States

**Facility:** Site US10005

**State:** Florida

**Zip:** 33880

**Location 11:**

**City:** Augusta

**Country:** United States

**Facility:** Site US10036

**State:** Georgia

**Zip:** 30909

**Location 12:**

**City:** Boston

**Country:** United States

**Facility:** Site US10002

**State:** Massachusetts

**Zip:** 02114

**Location 13:**

**City:** Omaha

**Country:** United States

**Facility:** Site US10001

**State:** Nebraska

**Zip:** 985540

**Location 14:**

**City:** Reno

**Country:** United States

**Facility:** Site US10027

**State:** Nevada

**Zip:** 89511

**Location 15:**

**City:** Nashville

**Country:** United States

**Facility:** Site US10012

**State:** Tennessee

**Zip:** 37203

**Location 16:**

**City:** Abilene

**Country:** United States

**Facility:** Site US10010

**State:** Texas

**Zip:** 79606

**Location 17:**

**City:** Austin

**Country:** United States

**Facility:** Site US10015

**State:** Texas

**Zip:** 78705

**Location 18:**

**City:** Houston

**Country:** United States

**Facility:** Site US10013

**State:** Texas

**Zip:** 77030

**Location 19:**

**City:** McAllen

**Country:** United States

**Facility:** Site US10030

**State:** Texas

**Zip:** 78503

**Location 20:**

**City:** San Antonio

**Country:** United States

**Facility:** Site US10009

**State:** Texas

**Zip:** 78240-1502

**Location 21:**

**City:** Charlottesville

**Country:** United States

**Facility:** Site US10017

**State:** Virginia

**Zip:** 22903

#### Overall Officials

**Official 1:**

**Affiliation:** Astellas Pharma Europe B.V.

**Name:** Global Medical Lead

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**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.

**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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**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.

**URL:** https://www.clinicalstudydatarequest.com/

### References Module

#### References

**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.

**PMID:** 31388454

#### See Also Links

**Label:** Link to results on the Astellas Clinical Study Results website

**URL:** https://astellasclinicalstudyresults.com/study.aspx?ID=298

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000008268

- Term: Macular Degeneration

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M11261

- Name: Macular Edema

- Relevance: HIGH

- As Found: Macular Edema

- ID: M7657

- Name: Edema

- Relevance: HIGH

- As Found: Edema

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11260

- Name: Macular Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008269

- Term: Macular Edema

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004487

- Term: Edema

### Intervention Browse Module - Ancestors

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000006131

- Term: Growth Inhibitors

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M472

- Name: Ranibizumab

- Relevance: HIGH

- As Found: Dysfunction

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069579

- Term: Ranibizumab

### Misc Info Module

- Version Holder: 2024-05-24
