Clinical Trials Register

Summary
EudraCT Number:	2017-001172-36
Sponsor's Protocol Code Number:	DX211
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-05-03
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Finland - Fimea

A.2

EudraCT number

2017-001172-36

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.4.1

Sponsor's protocol code number

DX211

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Oculis ehf.
B.1.3.4	Country	Iceland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Oculis ehf.
B.4.2	Country	Iceland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Oculis ehf.
B.5.2	Functional name of contact point	Gudrun Asgrimsdottir
B.5.3	Address:
B.5.3.1	Street Address	Grandagardur 16
B.5.3.2	Town/ city	Reykjavik
B.5.3.3	Post code	101
B.5.3.4	Country	Iceland
B.5.6	E-mail	gudrun.asgrimsdottir@oculispharma.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	DexNP
D.3.4	Pharmaceutical form	Ear/eye drops, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dexamethasone
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	DexNP
D.3.9.3	Other descriptive name	DEXAMETHASONE PH. EUR.
D.3.9.4	EV Substance Code	SUB170672
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Ear/eye drops, suspension
D.8.4	Route of administration of the placebo	Ocular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Diabetic macular edema

E.1.1.1

Medical condition in easily understood language

Diabetic macular edema

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10012662
E.1.2	Term	Diabetic eye disease NOS
E.1.2	System Organ Class	100000004853

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this study is to evaluate the efficacy and safety of DexNP in the improvement of visual acuity in subjects with DME.

E.2.2

Secondary objectives of the trial

Safety
Morphologic changes
Quality of Life

E.2.3

Trial contains a sub-study

E.3

Principal 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

E.4

Principal 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., senile miosis), or lack cooperation that, in the opinion of the evaluating Investigator, would interfere with any study procedures, evaluations, or interpretation of data
t) Have any ocular condition that, in the opinion of the Investigator, may require intervention, interfere with evaluations of efficacy or safety or interpretation of data collected in the study
u) Have an estimated Glomerular Filtration Rate (eGFR) of < 15mL/min/1.73m2 as per CKD-EPI equation at Visit 1
v) Have a systolic blood pressure < 90 or > 160 mmHg and / or a diastolic blood pressure > 100 mmHg at Visit 1
w) Have a known or suspected hypersensitivity to any components of the test agent, the comparator drug, or to fluorescein
x) Be a female subject who is pregnant or lactating or has a positive pregnancy test at Visit 1 or has been pregnant within 6 months before Visit 1 or breast-feeding within 3 months before Visit 1, or planning to become pregnant within 9 months from Visit 1
y) Have participated in any interventional clinical study or been treated with any investigational drugs within 30 days or 5 half-lives of the investigational drug, whichever is longer, prior to the initiation of Visit 1
z) Have any other condition, which in the opinion of the evaluating Investigator, precludes the subject’s participation in the trial

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint of the study is change in ETDRS Best Corrected Visual Acuity (BCVA) from baseline at 12 weeks.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

E.5.2

Secondary end point(s)

Secondary endpoints of the study are number of subjects with BCVA improvements of ≥10 and 15 letters in comparison to
baseline, central macular thickness on OCT, intraocular pressure, patient satisfaction

E.5.2.1

Timepoint(s) of evaluation of this end point

12 weeks

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

English LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

144

F.4.2.2

In the whole clinical trial

144

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Standard of care

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-06-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-03-28

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