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Active, Not Recruiting

NCT Number: NCT04101877

The Sahlgrenska Anti-VEGF Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology

Mölndal, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bevacizumab Injection

Drug

25 mg/ml

Other names: Avastin

Aflibercept Injection

Drug

40 mg/ml

Other names: Eylea

Primary outcomes

  1. Number of injections

    Time frame: Two years

    Number of intravitreal injections

Secondary outcomes

  1. Best-corrected visual acuity (BCVA), distance

    Time frame: Two years

    ETDRS

  2. Best-corrected visual acuity (BCVA), near

    Time frame: Two years

    LIX

  3. Macular thickness (Central Retinal Thickness; CRT)

    Time frame: Two years

    μm

  4. Intraocular pressure (IOP)

    Time frame: Two years

    mmHg

  5. Recurrence interval

    Time frame: Two years

    Maximum number of weeks from last injection to relapse, at first and last relapse.

  6. Durability

    Time frame: Two years

    Longest inactive interval detected (number of weeks).

  7. Cost efficiency

    Time frame: Two years

    Quality-adjusted life years (QALY), cost-per-QALY is measured with the EuroQol-5 Dimension (EQ-5D) questionnaire.

    EQ-5D consists of five subscales: mobility, self-care, usual activities, discomfort/pain and anxiety/depression. The subscales measure different aspects of health and well-being where the subject is asked to rank each subscale from 1 (no problems) to 3 (major problems). These answers are converted to a score between 0 (=death) to 1 (=full health). The subscales are converted to a weighted mean which ranges from 0 (death) to 1 (full health). Negative values may exists for conditions worse than death. The weighting differs between geographic areas; for Sweden, the UK weighting scale is used.

  8. Vision-related quality of life

    Time frame: Two years

    National Eye Institute Visual Functioning Questionnaire -25 (NEI VFQ-25) questionnaire is based on 25 questions (items) where the subject is asked questions on visual function, daily activities and social consequences of visual function. The questions have answers on a 5- or 6-grade scale which are converted to a scale from 0 (no function/worst consequence) to 100 (no problems). The 25 items are clustered into 12 subscales. Items within each subscale are averaged to create the subscale scores according to the NEI VFQ-25 scoring algorithm. In addition, a composite score for all 12 subscales are created as an average of these. Minimum score is 0 and maximum score is 100 for each item, subscale and the composite score.

  9. Cost-benefit

    Time frame: Two years

    The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It represents the average incremental cost associated with 1 additional unit of the measure of effect and is given in Euro.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study 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

Acronym: SAHLVE

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Sep 24, 2019
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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