NCT04101877Active, not recruitingPhase 2
The Sahlgrenska Anti-VEGF Study
The Sahlgrenska Anti-VEGF (SAHLVE) Study - a Prospective Randomized Double-blind Comparison of Bevacizumab and Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
The study investigates whether patients treated for neovascular (wet) age-related macular degeneration (AMD), with intravitreal injection with bevacizumab (Avastin) after two years need more injections with retained therapy response compared to patients being treated with intravitreal injection with aflibercept (Eylea). 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 402 (estimated)
- First submitted
- 13 Sept 2019
- Start date
- 3 Sept 2020
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Macular degeneration
- NCT number
- NCT04101877
- EU CT number
- 2023-506317-22-00
- EudraCT number
- 2018-004438-14
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 402
- From 3 Sept 2020 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received treatment for the neovascular (wet) form of age-related macular degeneration.
Other illness
- Other eye disease in the current study eye that affects visual acuity or the possibility of examining fundus, according to the investigator's assessment.
- Diagnosed with diabetes (all types).
- 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.
- 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.
Other
- 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.
- Unregulated intraocular pressure (IOP) \> 30 mmHg despite pharmacological treatment in the current study eye.
- 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).
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska University Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Molndal | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.