Clinical trial NCT04101877: The Sahlgrenska Anti-VEGF Study
Official title: The Sahlgrenska Anti-VEGF (SAHLVE) Study - a Prospective Randomized Double-blind Comparison of Bevacizumab and Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2019-09-24
Enrollment: 402
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, randomized, double-blind
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of injections
timeFrame: Two years
Secondary outcomes:
measure: Best-corrected visual acuity (BCVA), distance
timeFrame: Two years
measure: Best-corrected visual acuity (BCVA), near
timeFrame: Two years
measure: Macular thickness (Central Retinal Thickness; CRT)
timeFrame: Two years
measure: Intraocular pressure (IOP)
timeFrame: Two years
measure: Recurrence interval
timeFrame: Two years
measure: Durability
timeFrame: Two years
measure: Cost efficiency
timeFrame: Two years
measure: Vision-related quality of life
timeFrame: Two years
measure: Cost-benefit
timeFrame: Two years
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology
Study officials:
affiliation: Vastra Gotaland Region
name: Madeleine Zetterberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: