The Sahlgrenska Anti-VEGF Study

  • STATUS
    Recruiting
  • End date
    Sep 4, 2024
  • participants needed
    402
  • sponsor
    Vastra Gotaland Region
Updated on 4 February 2021

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 on4 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent
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)
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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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