Clinical Trial Page

Summary
EudraCT Number:2020-004933-19
Sponsor's Protocol Code Number:DROPROP1
National Competent Authority:Sweden - MPA
Clinical Trial Type:EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:2021-01-25
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
A. Protocol Information
A.1Member State ConcernedSweden - MPA
A.2EudraCT number2020-004933-19
A.3Full title of the trial
A Randomized Intervention, Multi-Center Study to Determine the Role of Dexamethasone eye drops against proliferative retinopathy of prematurity
En randomiserad, multicenter interventionsstudie i syfte att kartlägga om ögondroppar med Dexamethason förhindrar utvecklibg av proliferativ prematuritetsretinopati
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Can steroid eyedrops prevent severe ROP
Kan kortisondroppar i ögat förhindra svår ROP?
A.3.2Name or abbreviated title of the trial where available
DROPROP
A.4.1Sponsor's protocol code numberDROPROP1
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorRegion Västra Götaland, Sahlgrenska Universitetssjukhuset
B.1.3.4CountrySweden
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportRegion Västra Götaland, Sahlgrenska University Hospital
B.4.2CountrySweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationThe Sahlgrenska Center for Pediatric Ophthalmology Research
B.5.2Functional name of contact pointCarola Pfeiffer Mosesson
B.5.3 Address:
B.5.3.1Street AddressVitaminvägen 21
B.5.3.2Town/ cityGothenburg
B.5.3.3Post code41650
B.5.3.4CountrySweden
B.5.4Telephone number+46709126127
B.5.5Fax number+4631848952
B.5.6E-mailcarola.pfeiffer-mosesson@gu.se
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Dexafree
D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires THEA 12, rue Louis Blériot 63017 Clermont-Ferrand Cedex 2 Frankrike
D.2.1.2Country which granted the Marketing AuthorisationSweden
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameDexafree
D.3.4Pharmaceutical form Eye drops
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOcular use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboEye drops
D.8.4Route of administration of the placeboOcular use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Retinopathy of Prematurity
Prematuritetsretinopati
E.1.1.1Medical condition in easily understood language
Abnormal retinal vascular development in a preterm baby
Onormal kärlutveckling i ögat hos prematurfödda barn
E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.1
E.1.2Level LLT
E.1.2Classification code 10036858
E.1.2Term Proliferative retinopathy
E.1.2System Organ Class 100000004853
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
Reduce frequency of ROP needing treatment
Minska förekomst av behandlingskrävande ROP
E.2.2Secondary objectives of the trial
-Improve visual outcome at 2.5 and 5 years
-reduce frequency of refractive errors
-improve retinal morphology
- förbättra synutfall vid 2.5 och 5 års ålder
- minska förekomst av refraktionsfel
- förbättra retinal morfologi
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1) preterm infants born <30 weeks of gestation
2) ROP zone I without plus disease with either
a. stage 1 or b. stage 2 or
3) ROP posterior zone II without plus disease with either
a.Posterior ROP stage 2
or
b. ROP stage 3 with or without notch in zone I

1) Barn som föds <30 veckors gestationsålder
2) ROP zon I utan plus disease med
a. stadium 1 eller b. stadium 2 eller
3) ROP zon II utan plus disease med antingen
a. posterior ROP stadium 2 eller
b. stadium 3 med eller utan notch i zon 1
E.4Principal exclusion criteria
1) Ocular infection
2) If the patient is judged unsuitable for the study by treating neonatologist/paediatrician or ophthalmologist for any other reason
1) Ögoninfektion
2) Om patienten anses vara olämplig av någon anledning för deltagande i studien av neonatolog/pediatriker alternativt ögonläkaren.
E.5 End points
E.5.1Primary end point(s)
1) Reduced frequency of infants treated with laser and/or AntiVEGF for Type 1 ROP
1) Minskad frekvens barn som behandlas med laser och eller AntiVEGF för Typ 1 ROP
E.5.1.1Timepoint(s) of evaluation of this end point
1) around 40 weeks gesttational age (after finalised ROP screening)
1) vid fullgången tid, ca 40 veckors gestationsålder (efter avslutad screeninng)
E.5.2Secondary end point(s)
2) Improved visual outcome at 2.5 and 5 years
3) Reduced frequency of refractive errors
4) Improved retinal morphological oucome at 1 year of age
2) Förbättrat synutfall vid 2.5 och 5 års ålder
3) minskad frekvens refraktionsfel
4) förbättrad retinal morfologi vid 1 års ålder
E.5.2.1Timepoint(s) of evaluation of this end point
2) 2.5 and 5 years
3) 2.5 and 5 years
4) 1 year
2) 2.5 och 5 års ålder
3) 2.5 och 5 års ålder
4) 1 års ålder
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis Yes
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind Yes
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned11
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee Yes
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
LVLS
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 100
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
F.1.1.2.1Number of subjects for this age range: 100
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) Yes
F.1.1.4.1Number of subjects for this age range: 100
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
infants to be included-parents have to give informed consent
Prematurfödda barn kommer inkluderas i studien vilka ej kan ge sitt medgivande så föräldrarna får ge tillåtelse att barnen inkluderas i studien
F.3.3.7Others Yes
F.3.3.7.1Details of other specific vulnerable populations
Preterm infants
Prematurfödda barn
F.4 Planned number of subjects to be included
F.4.1In the member state90
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 90
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)
None
Inga
G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1Name of Organisation Region Skåne University Hospital, Lund
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 2
G.4.1Name of Organisation Region Jönköpings län, Ryhovs sjukhus Jönköping
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 3
G.4.1Name of Organisation Region Västra Götaland Skaraborgs Sjukhus, Skövde
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 4
G.4.1Name of Organisation Region Uppsala Akademiska Sjukhuset, Neuro sektion ögon
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 5
G.4.1Name of Organisation Norrlands Universitetssjukhus
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 6
G.4.1Name of Organisation St Eriks Ögonsjukvård
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 7
G.4.1Name of Organisation Universitetssjukhuset Linköping
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 8
G.4.1Name of Organisation Gävle Sjukhus
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 9
G.4.1Name of Organisation Centralsjukhuset Karlstad
G.4.3.4Network Country Sweden
G.4 Investigator Network to be involved in the Trial: 10
G.4.1Name of Organisation Västmanlands sjukhus
G.4.3.4Network Country Sweden
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2021-03-11
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial Status

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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