Overview
Sponsor-declared trial summary
Age-Associated Macular Degeneration
Main objective: 1. To determinate if Bevacizumab is as effective as ranibizumab after one year of treatment for patients with AMD. Key Secondary objective: 2. To evaluate the influence of different polymorphisms in the following genes on a saliva sampling: VEGFA, CFH, CTGF/CCN2, ARMS2, HTRA1, OR52B4, LOC100287225, LEPR…
Key facts
- Sponsor
- Consorci Mar Parc De Salut De Barcelona
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Decision date (initial)
- 2024-10-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518990-33-00
- EudraCT number
- 2019-003204-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Therapy
Main objective:
1. To determinate if Bevacizumab is as effective as ranibizumab after one year of treatment for
patients with AMD.
Key Secondary objective:
2. To evaluate the influence of different polymorphisms in the following genes on a saliva sampling:
VEGFA, CFH, CTGF/CCN2, ARMS2, HTRA1, OR52B4, LOC100287225, LEPR, SERPINF1 in the
response to treatment of the two drugs.
Conditions and MedDRA coding
Age-Associated Macular Degeneration
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10064930 | Age-related macular degeneration | 100000004853 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients diagnosed with neovascular Age-related Macular Degeneration and: Age of 50 years or older. That at the discretion of the ophthalmologist has an indication of receiving treatmentwith an anti VEGF agent as usual in clinical practice. Without previous treatment in the eye under study (no previous antiVEGF treatment for AMD).
Exclusion criteria 7
- Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
- Patients with other eye diseases, p.eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study
- Concomitant administration of antiVEGF for other non-ocular diseases
- High cardiovascular risk within last 3 months (poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery) or if patient is unstable at the time of planned Intravitreal injection, except for stable patients with favorable consultation with additional relevant physicians prior to the administration (p.e. cardiologist)Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma
- Hypersensitivity to the active substance or to the excipients
- Diabetic retinopathy documented
- Pregnant or nursing (lactating) women.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Visual acuity score measured on ETDRS at 4 meters of initial distance or Snellen with conversion to ETDRS if necessary, using the method proposed by Rosenfeld et al, between the baseline and final evaluations. Main outcome will be assessed at 1 year.Genetic polymorphism: Saliva samples will be collected using oral swabs suitable for obtaining DNA. The genomic DNA will be obtained from a first digestion of the sample wit
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153901 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 1.25 mg milligram(s)
- Max total dose
- 15 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB22314 · Substance
- Active substance
- Ranibizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 0.05 ml millilitre(s)
- Max total dose
- 0.05 ml millilitre(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Consorci Mar Parc De Salut De Barcelona
- Sponsor organisation
- Consorci Mar Parc De Salut De Barcelona
- Address
- Passeig Maritim De La Barceloneta 25-29
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Ana Aldea
Public contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Marta López
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 574 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol_V7_13032025_censurado | 1 |
| Protocol (for publication) | protocolo vs 5 vs 16012024_clean_Censurado | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition | 1 |
| Recruitment arrangements (for publication) | recruitment procedure | 1 |
| Subject information and informed consent form (for publication) | HI_CI vs1 vs 160012024 _OBSERVACIONAL_Censurado | 1 |
| Subject information and informed consent form (for publication) | HIP_CI_V1_20122021_IP2023_Censurado | 1 |
| Subject information and informed consent form (for publication) | HIP_CI_V3_13032025_OBS_trackchanges | 1 |
| Subject information and informed consent form (for publication) | HIP_CI_V3_13032025_trackchanges | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | CTIS Blank Document for Transition | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FT_1221673001_biosimilar_ranivisio | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FT_1221691001_biosimilar_ximluci | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FT_lucentis | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | spc_BEVACIZUMAB_2021_12_20 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Spain | Acceptable 2024-10-25
|
2024-10-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-19 | Acceptable 2025-05-16
|
||
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-02 | Spain | Acceptable | 2025-06-26 |