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Neovascular Age-related Macular DegenerationPhase 2SAHLVENCT04101877

The Sahlgrenska Anti-VEGF Study

A Phase 2 study testing Bevacizumab Injection and Aflibercept Injection in people with Neovascular Age-related Macular Degeneration, run by Vastra Gotaland Region at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Bevacizumab Injection and Aflibercept Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
1 siteSweden
Study dates
3 Sep 2020to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

Sweden1 site

  • Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology

    Mölndal

Other trials in Sweden

About this 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

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.

Being tested
Bevacizumab Injection, Aflibercept Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab InjectionDrug

    Also called Avastin

    25 mg/ml

  • Aflibercept InjectionDrug

    Also called Eylea

    40 mg/ml

Study groups in NCT04101877
Study groupRoleWhat they receive
AvastinExperimentalbevacizumab 25 mg/ml, intravitreal administration, 0.05 ml (1.25 mg)
Receives: Drug: Bevacizumab Injection
EyleaActive comparatoraflibercept 40 mg/ml, intravitreal administration, 0.05 ml (2 mg)
Receives: Drug: Aflibercept Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of injections

    Number of intravitreal injections

    Measured: Two years

Secondary outcomes (9)

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

    ETDRS

    Measured: Two years

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

    LIX

    Measured: Two years

  3. Macular thickness (Central Retinal Thickness; CRT)

    μm

    Measured: Two years

  4. Intraocular pressure (IOP)

    mmHg

    Measured: Two years

  5. Recurrence interval

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

    Measured: Two years

  6. Durability

    Longest inactive interval detected (number of weeks).

    Measured: Two years

  7. Cost efficiency

    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.

    Measured: Two years

  8. Vision-related quality of life

    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.

    Measured: Two years

  9. Cost-benefit

    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.

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2019
  2. Study start3 Sep 2020
  3. Primary completionOct 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, controlled, randomized, double-blind
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
402 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04101877
Sponsor's protocol ID
SAHLVE
Other IDs
2018-004438-14, 2018
Acronym
SAHLVE
Status last verified
Oct 2025
First submitted
13 Sep 2019
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared, however, the results (group-level) will be available within one year of study completion.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab Injection and Aflibercept Injection in people with Neovascular Age-related Macular Degeneration, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of injections (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04101877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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