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



Status:Completed
Conditions:Cardiology, Ocular, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - 85
Updated:3/8/2019
Start Date:January 12, 2015
End Date:August 12, 2016

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
21
sites
Phoenix, Arizona 85014
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Abilene, Texas 79606
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Arcadia, California 91007
?
mi
from
Arcadia, CA
Click here to add this to my saved trials
Augusta, Georgia 30909
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
46 Joy Street
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
McAllen, Texas 78503
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Omaha, Nebraska 68114
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Palm Desert, California 92260
?
mi
from
Palm Desert, CA
Click here to add this to my saved trials
Reno, Nevada 89511
?
mi
from
Reno, NV
Click here to add this to my saved trials
Sacramento, California 95817
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas 78209
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Tucson, Arizona 85719
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Winter Haven, Florida 33880
?
mi
from
Winter Haven, FL
Click here to add this to my saved trials