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

2025-520640-15-00 Phase III and Phase IV (Integrated) Ongoing, recruiting

Start 30 Jan 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)
Status Ongoing, recruiting
Participants planned 110
Countries 1
Sites 1

pterygium

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

Key facts

Sponsor
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Eye Diseases [C11], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
Trial duration
30 Jan 2025 → ongoing
Decision date (initial)
2025-01-30
Transition trial
Yes
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2025-520640-15-00
EudraCT number
2018-003042-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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

Secondary objectives 3

  1. To evaluate and compare the epithelialization time after surgery in both techniques.
  2. To evaluate tissue healing in both techniques.
  3. To evaluate the safety and surgical and postoperative complications of both techniques: scleritis, persistent epithelial defect, graft retraction, graft loss, and intraocular hypertension secondary to corticosteroids.

Conditions and MedDRA coding

pterygium

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Primary pterygium, unilateral or bilateral, with fibrovascular proliferation growth.
  2. Patients aged between 20 and 60 years.
  3. Corneal invasion with risk of visual impairment and/or ocular discomfort due to pterygium.

Exclusion criteria 5

  1. Previous pterygium surgery (recurrent pterygium).
  2. Pseudopterygium.
  3. Use of topical or systemic immunosuppressive or immunomodulatory treatment.
  4. Chronic use of topical ocular treatment except for artificial tears.
  5. History of eyelid or ocular surface disease.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Recurrence rate in both techniques. Defined as the number of recurrences per technique divided by the surgeries performed with amniotic membrane implant and those using fibrin-rich growth factor graft. Recurrence is understood as the appearance of fibrovascular proliferation invading the corneal limbus and the cornea. This will be evaluated during follow-up at one month, two months, three months, six months, and one year after the intervention.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Endoret-Prgf

PRD11962177 · Product

Active substance
Fibrin Matrix
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
1 U unit(s)
Max total dose
1 U unit(s)
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
ATC code
S01KX — OTHER SURGICAL AIDS
MA holder
FUNDACIO INSTITUT DE RECERCA DE L HOSPITAL DE LA SANTA CREU I SANT PAU
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

19 Total trials 14 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Address
Calle Sant Quinti 77-79
City
Barcelona
Postcode
08041
Country
Spain

Scientific contact point

Organisation
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Contact name
Alejandra Espinosa

Public contact point

Organisation
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Contact name
Alejandra Espinosa

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 110 1
Rest of world — 0 —

Investigational sites

Spain

1 site · Ongoing, recruiting
Hospital De La Santa Creu I Sant Pau
Ophthalmology, Calle De San Antonio Maria Claret 167, 08025, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2025-01-30 2025-01-30

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2025-520640-15 pub 3
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICF pub 3

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-01-27 Spain Acceptable with conditions
2025-01-30
 2025-01-30