The Sahlgrenska Anti-VEGF Study (SAHLVE)

Vastra Gotaland Region

Status and phase: Active, not recruiting; Phase 2

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Bevacizumab Injection; Drug: Aflibercept Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04101877

SAHLVE

2018-004438-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 402 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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402 participants in 2 patient groups

Avastin

Experimental group

Description:

bevacizumab 25 mg/ml, intravitreal administration, 0.05 ml (1.25 mg)

Treatment:

Drug: Bevacizumab Injection

Eylea

Active Comparator group

Description:

aflibercept 40 mg/ml, intravitreal administration, 0.05 ml (2 mg)

Treatment:

Drug: Aflibercept Injection