Efficacy and safety of dexamethasone nanoparticles eye drops in diabetic macular edema.

Phase 1

• Conditions: Diabaetic macular edema; MedDRA version: 20.0 Level: LLT Classification code 10012662 Term: Diabetic eye disease NOS System Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-001172-36-DK
• Lead Sponsor: Oculis ehf.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

Subjects must:
a)Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central macular thickness, CMT, of = 310µm by SD-OCT at baseline (Visit 2) (as measured by the Investigator and confirmed by the Reading Center)
b)Have definite retinal thickening in the study eye due to DME involving the central macula based on the Investigator’s clinical evaluation and by SD-OCT; Note: If the DME consists of circumscribed, focal leakage that the evaluating Investigator believes should be treated with laser and no other treatments, the eye is not eligible to be a study eye.
c)Have an ETDRS BCVA letter score = 73 (Snellen 20/40) and = 24 (Snellen 20/320) in the study eye at baseline (Visit 2)
d)Have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of = 12.0% at Visit 1
e)Have a negative urine pregnancy test at Visit 1, if female of childbearing potential those who have experienced menarche and who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate birth control throughout the study period. Adequate birth control is defined as hormonal – oral, implantable, injectable, or transdermal contraceptives; mechanical – spermicide in conjunction with a barrier such as condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner. For non- sexually active females, abstinence may be regarded as an adequate method of birth control;
f)Agree to not participate in another interventional study after providing informed consent and until the study is completed
g)Provide written informed consent prior to any study procedure being performed and be able and willing to follow all instructions and attend all study visits
h)Be 18-85 years of age at screening (Visit 1), of either sex and any race or ethnicity

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 69

Exclusion Criteria

Subjects must not:
a)Have macular edema considered to be due to a cause other than DME; Note: an eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction;(2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema, or (3) the macular edema is considered to be related to another condition such as age-related macular degeneration, uveitis, retinal vein occlusion, or drug toxicity
b)Have a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that is likely to be decreasing BCVA by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal)
c)Have significant macular ischemia.
d)Have any other ocular disease that may cause substantial reduction in BCVA, including, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases
e)Have active peri-ocular or ocular infection (e.g., blepharitis, keratitis, scleritis, or conjunctivitis)
f)Have a history of non-infectious uveitis
g)Have high myopia (-8 diopter or more correction)
h)Must NOT wear contact lenses during the 12 week active treatment study period
i)Have a history of any ocular surgery within 3 months prior to Visit 1
j)Have a history of YAG laser capsulotomy within 3 months prior to Visit 1;
k)Have a history of panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Visit 1 or an anticipated need for PRP during the course of the study
l)Have a history of prior IVT, subtenon, or periocular, non-sustained release, steroid therapy within 3 months prior to Visit 1 (e.g., triamcinolone)
m)Have a history of intravitreal sustained release dexamethasone therapy within six months prior to Visit 1
n)Have a history of intravitreal sustained release fluocinolone within three years prior to Visit 1
o)Have a history of prior treatment of intravitreal (IVT) aflibercept within 8 weeks and ranibizumab/bevacizumab within 6 weeks of Visit 1
p)Have a history of prior treatment for DME with any other (than previously listed) approved treatment which is not labeled for DME within one year prior to Visit 1
q)Have high-risk proliferative diabetic retinopathy (PDR), defined in the ETDRS study as at least one of the following:
•New vessels within one disc diameter of the optic disc (NVD) = 1/3 disc area;
•Any NVD with vitreous or pre-retinal hemorrhage;
•New vessels elsewhere in the retina (NVE) = ½ disc area and pre-retinal or vitreous hemorrhage;
r)Have uncontrolled ocular hypertension or glaucoma in either eye, defined as intraocular pressure (IOP) = 22 mmHg on more than 1 IOP lowering medications at Visit 1
s)Have poor media clarity, pupillary constriction (i.e., se

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified