Clinical Trials Register

Summary
EudraCT Number:	2014-005472-29
Sponsor's Protocol Code Number:	DROP-ROP-0.2%
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-04
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-005472-29

A.3

Full title of the trial

Safety and efficay of 0.2% propranolol eye drops in newborns with retinopathy of prematurity: a pilot study

Sicurezza e efficacia del trattamento con propranololo 0.2% per uso topico nei neonati affetti da retinopatia del prematuro: studio pilota

A.3.1

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

Safety and efficay of 0.2% propranolol eye drops in newborns with retinopathy of prematurity

Sicurezza e efficacia del trattamento con propranololo 0.2% per uso topico nei neonati affetti da retinopatia del prematuro

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

DROP-ROP-0.2%

A.5.4

Other Identifiers

Name:

Number:

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	AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
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	Azienda Ospedaliero Universitaria Meyer
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	AZIENDA OSPEDALIERO UNIVERSITARIA MEYER
B.5.2	Functional name of contact point	CLINICAL TRIAL OFFICE
B.5.3	Address:
B.5.3.1	Street Address	VIALE PIERACCINI 24
B.5.3.2	Town/ city	FIRENZE
B.5.3.3	Post code	50139
B.5.3.4	Country	Italy
B.5.4	Telephone number	0555662425
B.5.5	Fax number	na
B.5.6	E-mail	clinicaltrialoffice@meyer.it

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	na
D.2.1.1.2	Name of the Marketing Authorisation holder	na
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	na
D.3.2	Product code	na
D.3.4	Pharmaceutical form	Eye drops, solution
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	PROPRANOLOLO
D.3.9.2	Current sponsor code	PROPRANOLOLO
D.3.9.3	Other descriptive name	PROPRANOLOL
D.3.10	Strength
D.3.10.1	Concentration unit	µg/µl microgram(s)/microlitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

RETINOPATHY OF PREMATURITY

RETINOPATIA DEL PREMATURO

E.1.1.1

Medical condition in easily understood language

RETINOPATHY OF PREMATURITY

RETINOPATIA DEL PREMATURO

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	20.1
E.1.2	Level	PT
E.1.2	Classification code	10038933
E.1.2	Term	Retinopathy of prematurity
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the safety and efficacy of 0.2% propranolol eye drops to stop the progression of classic retinopathy of prematury (ROP) stage 1 towards stage 2 plus or stage 3 plus, therefore avoiding interventions such as laser therapy or anti-VEGF therapy.

Valutare la sicurezza e l¿efficacia del trattamento con propranololo somministrato per via topica sotto forma di gocce allo 0.2% in soluzione fisiologica nell¿arrestare la progressione della ROP classica Stadio 1 verso lo stadio 2 con plus o 3 con plus e quindi verso la necessit¿ di un trattamento con fotocoagulazione laser o trattamento con anti-VEGF

E.2.2

Secondary objectives of the trial

Evaluate the efficacy of 0.2% propranolol eye drops to stop the progression of classic retinopathy of prematury (ROP) stage 1 towards subsequent stages

Valutare l¿efficacia del trattamento con propranololo somministrato per via topica sotto forma di gocce allo 0.2% in soluzione fisiologica nell¿arrestare la progressione della ROP classica Stadio 1 verso gli stadi successivi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Newborns with gestational ages between 23 and 32 weeks affected by classic stage 1 ROP.
2. Parents informed consent.

1. Neonati con età gestazionale compresa tra le 23 e 32 settimane con presenza di ROP classica Stadio 1
2. Consenso informato dei genitori.

E.4

Principal exclusion criteria

Newborns with:
1. cardiac failure
2. recurrent episodes of bradycardia (BPM < 90)
3. atrioventricular block 2nd and/or 3rd degrees
4. significant cardiovascular congenital anomalies (except of patent foramen ovale, patent ductus arteriosus o defects of the interventricular septum)
5. hypotension
6. serious renal failure
7. cerebral bleeding (ongoing)
8. other diseases for which the use of beta blockers is contraindicated
9. ROP stage > 1

Neonati con:
1. scompenso cardiaco;
2. ricorrenti episodi di bradicardia (frequenza cardiaca < 90/minuto);
3. blocco atrioventricolare di 2° e/o 3° grado;
4. significative anomalie congenite cardiovascolari (escluse la pervietà del dotto arterioso, del forame ovale o piccoli difetti del setto interventricolare);
5. ipotensione;
6. grave insufficienza renale;
7. emorragia cerebrale in corso;
8. altre patologie che controindichino l’utilizzo di beta bloccanti;
9. quadro di ROP di grado superiore allo stadio 1.

E.5 End points

E.5.1

Primary end point(s)

1. Proportion of newborns who progress to stage 2 plus or 3 plus ROP zone II
2. Measurement of haematic propranolol concentration after 10 days of treatment (steady state)

1. Proporzione di neonati che evolvono a ROP zona II Stadio 2 con plus o 3 con plus disease
2. Misurazione dei valori di propranololemia in decima giornata di trattamento (steady-state)

E.5.1.1

Timepoint(s) of evaluation of this end point

1. maximun 90 days
2. 10 days from the beginning of the treatment

1. massimo 90 giorni
2. decima giornata di trattamento

E.5.2

Secondary end point(s)

Proportion of newborns who progress to stage 2 without plus ; Proportion of newborns who progress to stage 3 without plus ; Proportion of newborns who progress to stage 4 and 5 and experiencing partial or total retinal detachment; Proportion of newborns who need vitrectomy ; Frequency of adverse events

Proporzione di neonati che evolveranno a ROP stadio 2 senza plus; Proporzione di neonati che evolveranno a ROP stadio 3 senza plus; Proporzione di neonati che evolveranno a ROP stadio 4 e 5 con distacco di retina parziale o totale; Proporzione di neonati che avranno necessit¿ di vitrectomia; Frequenza eventi collaterali del trattamento con propranololo

E.5.2.1

Timepoint(s) of evaluation of this end point

maximum 90 days; maximum 90 days; maximum 90 days; maximum 90 days; Continuous safety monitoring for the entire length of the treatment

massimo 90 giorni; massimo 90 giorni; massimo 90 giorni; massimo 90 giorni; monitoraggio continuo per la durata del trattamento

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

Yes

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

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

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

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

Information not present in EudraCT

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

The last enrolled patient finishes the treatment schedule or has a complete retinal vascularization.

o studio si considerer¿ concluso totalmente quando l¿ultimo paziente arruolato completer¿ la scheda di trattamento o raggiunger¿ la completa vascolarizzazione della retina

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

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

Yes

F.1.1.2.1

Number of subjects for this age range:

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)

F.1.3

Elderly (>=65 years)

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Preterm newborn infants

Neonati pretermine

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

F.4.2.2

In the whole clinical trial

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)

According to normal clinical practice

I pazienti continueranno ad essere seguiti e trattati secondo pratica clinica

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

2015-06-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-14

P. End of Trial
P.	End of Trial Status	Completed

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