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

• Sponsor: Astellas Pharma Europe B.V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02302079
• Collaborator: (none)
• Enrollment: 96
• Locations: 21
• Arms: 3
• Actual Duration (Months): 19
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Diabetic Macular Edema	Drug: ASP8232; Drug: ranibizumab; Drug: Placebo; Other: Sham intravitreal (IVT) injection	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 12, 2015
• Actual Primary Completion Date: Aug 12, 2016
• Actual Study Completion Date: Aug 12, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3 [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 [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 [Baseline and Months 1, 2]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site US10021	Phoenix	Arizona	United States	85104
2	Site US10025	Tucson	Arizona	United States	85704
3	Site US10006	Arcadia	California	United States	91007
4	Site US10004	Beverly Hills	California	United States	90211
5	Site US10007	Palm Desert	California	United States	92260
6	Site US10011	Sacramento	California	United States	95819
7	Site US10031	Santa Ana	California	United States	92705
8	Site US10029	Golden	Colorado	United States	80401
9	Site US10016	Miami	Florida	United States	33126
10	Site US10005	Winter Haven	Florida	United States	33880
11	Site US10036	Augusta	Georgia	United States	30909
12	Site US10002	Boston	Massachusetts	United States	02114
13	Site US10001	Omaha	Nebraska	United States	985540
14	Site US10027	Reno	Nevada	United States	89511
15	Site US10012	Nashville	Tennessee	United States	37203
16	Site US10010	Abilene	Texas	United States	79606
17	Site US10015	Austin	Texas	United States	78705
18	Site US10013	Houston	Texas	United States	77030
19	Site US10030	McAllen	Texas	United States	78503
20	Site US10009	San Antonio	Texas	United States	78240-1502
21	Site US10017	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

• Astellas Pharma Europe B.V.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to results on the Astellas Clinical Study Results website

Publications

None provided.

• Responsible Party: Astellas Pharma Europe B.V.
• ClinicalTrials.gov Identifier: NCT02302079
• Other Study ID Numbers: 8232-CL-3001
• First Posted: Nov 26, 2014
• Last Update Posted: Mar 6, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Astellas Pharma Europe B.V.: ASP8232; Diabetes Mellitus; ranibizumab; Diabetic Macular Edema
• Additional relevant MeSH terms: Macular Edema; Diabetes Mellitus; Edema; Ranibizumab

Study Results

No Results Posted as of Mar 6, 2019