Clinical Trials Register

Summary
EudraCT Number:	2013-005091-17
Sponsor's Protocol Code Number:	26285/13
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-12-20
Trial 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

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-005091-17

A.3

Full title of the trial

Variation of choroidal Thickness 15 days after the first ranibizumab intravitreal injection in naïve patients WIth Neovascular age-related macular degeneration: pilot Study. –

A.3.1

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

Variation of choroidal Thickness 15 days after the first ranibizumab intravitreal injection in naïve patients WIth Neovascular age-related macular degeneration: pilot Study. –

A.4.1

Sponsor's protocol code number

26285/13

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	POLICLINICO GEMELLI
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	NOVARTIS
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	POLICLINICO GEMELLI
B.5.2	Functional name of contact point	OPHTHALMOLOGY
B.5.3	Address:
B.5.3.1	Street Address	LGO GEMELLI
B.5.3.2	Town/ city	ROME
B.5.3.4	Country	Italy

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	Yes
D.2.1.1.1	Trade name	LUCENTIS
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	RANIBIZUMAB
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RANIBIZUMAB
D.3.9.1	CAS number	347396-82-1
D.3.9.4	EV Substance Code	SUB22314
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Wet age-related macular degeneration

E.1.1.1

Medical condition in easily understood language

Wet age-related macular degeneration

E.1.1.2

Therapeutic area

Body processes [G] - Ocular Physiological Phenomena [G14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10067791
E.1.2	Term	Wet macular degeneration
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

To evaluate the choroidal thickness after the first study drug administration in naïve wAMD patients.

E.2.2

Secondary objectives of the trial

• To investigate the type of regression of choroidal thickness after ranibizumab treatment on its basal value.
• To investigate correlation between BCVA and choroidal thickness after ranibizumab treatment

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients > 50 years of age who have signed an informed consent before any assessment is performed
2. Visual impairment predominantly due to neovascular AMD (wet AMD).
3. Choroidal neovascularization (CNV) classic or minimally classic; in the new CNV classification type II.
4. Naïve eyes with no history of intravitreal injection before the study.
5. Active, newly diagnosed, untreated, angiographically documented CNV lesion (ie leakage on fluorescein angiography plus intraretinal, subretinal or sub RPE fluid on OCT) secondary to AMD.
6. CNV or sequelae of the CNV (ie, pigment epithelium detachment, subretinal or sub-RPE hemorrhage, blocked fluorescence, macular edema, or subretinal, sub-RPE or intraretinal fluid) involving the center of the fovea.
7. The total area of fibrosis comprising less than 50% of the lesion area.
8. BCVA score at Baseline between 78 and 23 letters as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at 4 meters, inclusively (approximate Snellen equivalent of 20/32 and 20/320).
If both eyes are eligible at Baseline, the investigator will decide the study eye based on his/her clinical judgment. The study eye will be treated with ranibizumab, according to the criteria defined for each treatment group.

E.4

Principal exclusion criteria

1. History of hypersensitivity to drugs of similar chemical classes of ranibizumab.
2. Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity while on treatment
3. Active intraocular inflammation (grade trace or above) in either eye.
4. Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye.
5. History of uveitis in either eye.
6. Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques.
7. Ocular disorders in the study eye that may confound interpretation of results, compromise visual acuity or require medical or surgical intervention during the program period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause (e.g. ocular histoplasmosis or pathologic myopia).
8. Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator’s judgment).
9. Neovascularization of the iris in either eye.
10. Evidence of vitreomacular traction in either eye.
11. Patients who are monocular or have a BCVA score in the non-study eye (fellow eye) ≤ 24 letters (approximate Snellen equivalent of 20/320) at Basal Visit.
12. Any use of eye drops for ocular disease as anti-glaucomatous or antinflammatory drugs.
13. History of eye surgery procedure (i.e. cataract surgery, vitrectomy or other surgery in the last 3 months).
14. Significant lens opacities.
15. History of myocardial infarction or cerebral vascular diseases.
16. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, aflibercept.) before the enrollment.
17. Known hypersensitivity to Ranibizumab or any component of the Ranibizumab formulation.
18. Pregnant or nursing (lactating) women.
19. Inability to comply with study procedures.

E.5 End points

E.5.1

Primary end point(s)

variation of choroidal thickness from baseline visit (first ranibizumab injection) to day 15.

E.5.1.1

Timepoint(s) of evaluation of this end point

15 days

E.5.2

Secondary end point(s)

• Type of regression (linear, squares, cubic, etc.) of choroidal thickness measured at different times ( 30, 60, 90 days) after ranibizumab treatment on its basal value.
• Correlation between BCVA and choroidal thickness measured at 30, 60 and 90 days after ranibizumab treatment.

E.5.2.1

Timepoint(s) of evaluation of this end point

30, 60, 90 days

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

E.6.4

Safety

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

choroidal morfological response to the therapy

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

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

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-12-20.

Yes

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.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)

normal clinical practice

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

2014-02-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-11-28

P. End of Trial
P.	End of Trial Status	Ongoing

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