Status:
ACTIVE_NOT_RECRUITING
The Sahlgrenska Anti-VEGF Study
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 injection...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT04101877
Start Date
September 3 2020
End Date
May 1 2027
Last Update
November 21 2025
Active Locations (1)
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1
Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal, Sweden