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The Sahlgrenska Anti-VEGF (SAHLVE) Study - a Prospective Randomized Double-blind Comparison of Bevacizumab and Aflibercept in Patients With Neovascular Age-related Macular Degeneration
EU CTIS ID: 2023-506317-22-00
What this study is testing
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?
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Other eye disease in the current study eye that affects visual acuity or the possibility of examining fundus, according to the investigator's assessment.
- 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).
- 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.
See the full eligibility criteria
- 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.
- Other eye disease in the current study eye that affects visual acuity or the possibility of examining fundus, according to the investigator's assessment.
- 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).
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.