Clinical trial • Phase IV • Ophthalmology
FIBRIN MATRIX for Pterygium
Phase IV trial of FIBRIN MATRIX for Pterygium.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Pterygium
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 27-01-2025
- First CTIS Authorization Date
- 30-01-2025
Trial design
Randomised, amniotic membrane graft (comparator) versus fibrin membrane graft with eye drops concentrated in autologous growth factors (investigational). no dose or schedule details specified.-controlled Phase IV trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Amniotic membrane graft (comparator) versus fibrin membrane graft with eye drops concentrated in autologous growth factors (investigational). No dose or schedule details specified.
- Target Sample Size
- 110
- Trial Duration For Participant
- 365
Eligibility
Recruits 110 Vulnerable population not selected; no specific consent or assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected; no specific consent or assent handling described in the record.
Inclusion criteria
- {"criterion_text":"- Primary pterygium, unilateral or bilateral, with fibrovascular proliferation growth.\n- Patients aged between 20 and 60 years.\n- Corneal invasion with risk of visual impairment and/or ocular discomfort due to pterygium."}
Exclusion criteria
- {"criterion_text":"- Previous pterygium surgery (recurrent pterygium).\n- Pseudopterygium.\n- Use of topical or systemic immunosuppressive or immunomodulatory treatment.\n- Chronic use of topical ocular treatment except for artificial tears.\n- History of eyelid or ocular surface disease."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Recurrence defined as the appearance of fibrovascular proliferation invading the corneal limbus and the cornea; evaluated at 1 month, 2 months, 3 months, 6 months, and 1 year post-intervention. Rate calculated as number of recurrences per technique divided by surgeries performed with each technique."}
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 84
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 110
Spain
- Earliest CTIS Part Ii Submission Date
- 16-01-2025
- Latest Decision Or Authorization Date
- 30-01-2025
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 110
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Ophthalmology
- Principal Investigator Name
- Zoraida del Campo Carrasco
- Principal Investigator Email
- zcampo@santpau.cat
- Contact Person Name
- Zoraida del Campo Carrasco
- Contact Person Email
- zcampo@santpau.cat
Sponsor
Primary sponsor
- Full Name
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- ENDORET-PRGF
- Active Substance
- FIBRIN MATRIX
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- prodAuthStatus=1
- Starting Dose
- 1 U unit(s)
- Maximum Dose
- 1 U unit(s)
- Combination Treatment
- Yes
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