The Sahlgrenska Anti-VEGF Study (SAHLVE)

  • STATUS
    Recruiting
  • End date
    Sep 11, 2024
  • participants needed
    402
  • sponsor
    Vastra Gotaland Region
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Updated on 11 May 2022
See if I qualify

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.

Details
Condition Neovascular Age-related Macular Degeneration
Treatment Aflibercept Injection, Bevacizumab Injection
Clinical Study IdentifierNCT04101877
SponsorVastra Gotaland Region
Last Modified on11 May 2022

Eligibility

 Yes No Not Sure

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)
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)
Included in another intervention study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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