Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
402
Countries
1
Sites
1
Neovascular (wet) age-related macular degeneration (AMD)
Are there difference in number of injections after two years in patients treated for neovascular (wet) age-related macular degeneration (AMD) with intravitreal injections with bevacizumab and aflibercept?
Key facts
- Sponsor
- Vaestra Goetalandsregionen, Vaestra Goetalandsregionen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 18 Sep 2019 → ongoing
- Decision date (initial)
- 2023-08-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Vaestra Goetalandsregionen
External identifiers
- EU CT number
- 2023-506317-22-00
- EudraCT number
- 2018-004438-14
- ClinicalTrials.gov
- NCT04101877
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Are there difference in number of injections after two years in patients treated for neovascular (wet) age-related macular degeneration (AMD) with intravitreal injections with bevacizumab and aflibercept?
Secondary objectives 1
- The study also aims to evaluate if there is a difference in best-corrected visual acuity, macular thickness, recurrence interval, durability, cost efficiency, as well as vision-related quality of life.
Conditions and MedDRA coding
Neovascular (wet) age-related macular degeneration (AMD)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Signed informed consent.
- ≥50 years, regardless of gender.
- Diagnosed with the neovascular (wet) form of age-related macular degeneration through diagnosed neovascular vascular membranes with OCT-A and, if necessary, also FA / ICG, according to clinical routine.
- Distance visual acuity ≥34 (ETDRS) on the current study eye.
Exclusion criteria 11
- Other eye disease in the current study eye that affects visual acuity or the possibility of examining fundus, according to the investigator's assessment.
- Previously received treatment for the neovascular (wet) form of age-related macular degeneration.
- Diagnosed with diabetes (all types).
- Degenerative state of the macula that prevents vision improvement such as central areolar atrophy or other pronounced dry AMD or fibrosis, in the current study eye.
- Other choroidal neovascularization (CNV) of the type PCV or due to grave myopia i.e. ≥ 6.0 diopters (D) or secondary to other retinal disease, in the current study eye.
- Unregulated intraocular pressure (IOP) > 30 mmHg despite pharmacological treatment in the current study eye.
- Have had a stroke or heart attack ≤6 months ago.
- Inability to access information (e.g. due to dementia) or inability to conduct examinations (e.g. ETDRS examination), according to the investigator's assessment.
- Inability to receive oral and written information in Swedish (in need of an interpreter).
- Included in another intervention study.
- Fertile woman i.e. a woman who has had menstruation for the past 12 months or has not undergone permanent sterilization (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of intravitreal injections after two years
Secondary endpoints 8
- Best-corrected visual acuity (BCVA), distance ETDRS and near LIX.
- Macular thickness (Central Retinal Thickness; CRT, in μm.
- Intraocular pressure (IOP) mmHg.
- Recurrence interval (maximum number of weeks from last injection to relapse), at first and last relapse.
- Durability (longest inactive interval detected, in number of weeks).
- Cost efficiency: Quality-adjusted life years (QALY), cost-per-QALY is measured with the EuroQol-5 Dimension (EQ-5D) questionnaire.
- Vision-related quality of life (NEI VFQ-25).
- Cost-benefit analysis: The incremental cost-effectiveness ratio (ICER).
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
- 1.25 mg milligram(s)
- Max treatment duration
- 24 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
Eylea 40 mg/mL solution for injection in a vial
PRD3117103 · Product
- Active substance
- Aflibercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01LA05 — -
- Marketing authorisation
- EU/1/12/797/002
- MA holder
- BAYER AG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Sahlgrenska University Hospital, Department of Ophthalmology
Public contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Sahlgrenska University Hospital, Department of Ophthalmology
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 402 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2019-09-18 | 2020-09-03 | 2024-12-09 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Sweden | Acceptable 2023-08-29
|
2023-08-30 |