Clinical Trials Register

Summary
EudraCT Number:	2018-003042-16
Sponsor's Protocol Code Number:	IIBSP-PTE-2018-35
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-10-09
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

Spain - AEMPS

A.2

EudraCT number

2018-003042-16

A.3

Full title of the trial

Randomized clinical trial to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery comparing it with amniotic membrane graft in terms of recurrence during the first year after surgery

Ensayo clínico aleatorizado para evaluar la eficacia del injerto de membrana de fibrina con colirio concentrado en factores de crecimiento autólogo en la cirugía de pterigio primario comparándola con el injerto de membrana amniótica en términos de recidiva durante el primer año después de la cirugía

A.3.1

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

Study to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery comparing it with amniotic membrane graft

Estudio para evaluar la eficacia del injerto de membrana de fibrina con colirio concentrado en factores de crecimiento autólogo en la cirugía de pterigio primario comparándola con el injerto de membrana amniótica

A.4.1

Sponsor's protocol code number

IIBSP-PTE-2018-35

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	Institut de Recerca H. de la Santa Creu i Sant Pau
B.1.3.4	Country	Spain
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	Institut de Recerca H. Santa Creu i Sant Pau
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Institut de Recerca H. Santa Creu i Sant Pau
B.5.2	Functional name of contact point	UICEC Sant Pau
B.5.3	Address:
B.5.3.1	Street Address	Sant Antoni Maria Claret 167
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08025
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34935537635
B.5.5	Fax number	+34935537812
B.5.6	E-mail	epenag@santpau.cat

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	PRP
D.3.4	Pharmaceutical form	Eye drops
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Conjunctival use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Platelet Rich Plasma (PRP)
D.3.9.3	Other descriptive name	AUTOLOGOUS PLASMA
D.3.9.4	EV Substance Code	SUB117286
D.3.10	Strength
D.3.10.1	Concentration unit	Gtt drop(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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	Yes
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Amniotic membrane
D.2.1.1.2	Name of the Marketing Authorisation holder	Banco de Sangre y Tejidos
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Amniotic membrane
D.3.4	Pharmaceutical form	Implantation matrix
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Amniotic membrane
D.3.9.3	Other descriptive name	Amniotic membrane
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

Pterigyum

Pterigion

E.1.1.1

Medical condition in easily understood language

Pterigyum

Pterigion

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 efficacy, through the rate of recurrence during the first postoperative year, of the fibrin membrane graft and concentrated eye drops in autologous growth factors in primary pterygium surgery, comparing it with the amniotic membrane graft.

Evaluar la eficacia, a través de la tasa de recidiva durante el primer año postoperatorio, del injerto de membrana de fibrina y colirio de concentrado en factores de crecimiento autólogos en la cirugía de pterigio primario, comparándola con el injerto de membrana amniótica.

E.2.2

Secondary objectives of the trial

- Evaluate and compare the epithelization time after surgery in both techniques
- Evaluate tissue healing in both techniques.
- Evaluate the safety and surgical and post-surgical complications of both techniques: scleritis, persistent epithelial defect, graft retraction, graft loss, intraocular hypertension secondary to corticosteroids.

- Evaluar y comparar el tiempo de epitelización tras la cirugía en ambas técnicas
- Evaluar la cicatrización tisular en ambas técnicas.
- Evaluar la seguridad y las complicaciones quirúrgicas y post quirúrgicas de ambas técnicas: escleritis, defecto epitelial persistente, retracción del injerto, pérdida del injerto, hipertensión intraocular secundaria a los corticoesteroides.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Uni or bilateral primary pterygium with growth of fibrovascular proliferation.
- Patients between 20 and 60 years old
- Corneal invasion with risk of visual affectation and / or eye discomfort due to pterygium.

- Pterigio primario uni o bilateral con crecimiento de la proliferación fibrovascular.
- Pacientes con edad entre 20 y 60 años
- Invasión corneal con riesgo de afectación visual y/o molestias oculares debidas al pterigio.

E.4

Principal exclusion criteria

- Prior pterygium surgery (recurrent pterygium)
- Pseudopterigio
- Use of topical or systemic immunosuppressive or immunomodulatory treatment
- Use of chronic topical ocular treatment except artificial tears
- Antecedents of palpebral disease or ocular surface

- Cirugía previa de pterigio (pterigio recidivante)
- Pseudopterigio
- Uso de tratamiento inmunosupresor o inmunomodulador tópico o sistémico
- Uso de tratamiento ocular tópico crónico excepto las lágrimas artificiales
- Antecedentes de enfermedad palpebral o de la superficie ocular

E.5 End points

E.5.1

Primary end point(s)

Recurrence rate. Defined as the number of recurrences per technique divided between surgeries performed with an amniotic membrane implant and those using a fibrin graft rich in growth factors. Understanding as recurrence the appearance of fibrovascular proliferation invading the corneal limbus and the cornea.

Tasa de recidivas. Definida como el número de recidivas por técnica dividida entre las cirugías realizadas con implante de membrana amniótica y las que se usa el injerto de fibrina rica en factores de crecimiento. Entendiendo como recidiva la aparición de proliferación fibrovascular invadiendo el limbo corneal y la córnea.

E.5.1.1

Timepoint(s) of evaluation of this end point

It will be evaluated at month, two months, three months, six months and the year after the intervention.

Se evaluará al mes, dos meses, tres meses, seis meses y al año tras la intervención.

E.5.2

Secondary end point(s)

- Epithelization time in both techniques. Defined as the number of days it takes to grow the epithelial cells on the amniotic membrane or fibrin graft by measuring it with fluorescein staining (epithelialization corresponds to negative staining). While there is an epithelial defect, the patient will be visited every 2 days.
- Correct tissue healing (YES / NO). Defined as the epithelization and healing of the conjunctiva with appearance similar to the healthy conjunctiva, without granulomas, without lines of fibrosis, without vascular proliferation.
- Security. Defined as the number of surgical complications in both techniques during the first three months of follow-up. The following are mainly registered: scleritis, persistent epithelial defect, graft retraction, graft loss, granuloma, intraocular hypertension secondary to corticosteroids.

- Tiempo de epitelización en ambas técnicas. Definido como el número de días que tarda en crecer las células epiteliales sobre el injerto de membrana amniótica o de fibrina midiéndolo con la tinción de fluoresceína (epitelización corresponde a tinción negativa). Mientras exista defecto epitelial el paciente se visitará cada 2 días.
- Cicatrización tisular correcta (SI/NO). Definida como la epitelización y cicatrización de la conjuntiva con aspecto similar a la conjuntiva sana, sin granulomas, sin líneas de fibrosis, sin proliferación vascular.
- Seguridad. Definida como el número de complicaciones quirúrgicas en ambas técnicas durante los primeros tres meses de seguimiento. Se registrarán principalmente las siguientes: escleritis, defecto epitelial persistente, retracción del injerto, pérdida del injerto, granuloma, hipertensión intraocular secundaria a los corticoesteroides.

E.5.2.1

Timepoint(s) of evaluation of this end point

It will be evaluated at month, two months, three months, six months and the year after the intervention.

Se evaluará al mes, dos meses, tres meses, seis meses y al año tras la intervención.

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

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

Yes

E.8.2.3.1

Comparator description

Membrana amniótica

Amniotic membrane

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

Última visita del último sujeto

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:

110

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

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

F.4 Planned number of subjects to be included

F.4.1

In the member state

110

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)

The expected normal treatment of the studied condition

El tratamiento habitual para la patología en estudio

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

2019-02-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-16

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

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