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The Sahlgrenska Anti-VEGF (SAHLVE) Study - a Prospective Randomized Double-blind Comparison of Bevacizumab and Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506317-22-00
Enrollment
402
Registered
2023-08-30
Start date
2019-09-18
Completion date
Unknown
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular (wet) age-related macular degeneration (AMD)

Brief summary

Number of intravitreal injections after two years

Detailed description

Best-corrected visual acuity (BCVA), distance ETDRS and near LIX., Macular thickness (Central Retinal Thickness; CRT, in μm., Intraocular pressure (IOP) mmHg., Recurrence interval (maximum number of weeks from last injection to relapse), at first and last relapse., Durability (longest inactive interval detected, in number of weeks)., Cost efficiency: Quality-adjusted life years (QALY), cost-per-QALY is measured with the EuroQol-5 Dimension (EQ-5D) questionnaire., Vision-related quality of life (NEI VFQ-25)., Cost-benefit analysis: The incremental cost-effectiveness ratio (ICER).

Interventions

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Sponsors

Vaestra Goetalandsregionen, Vaestra Goetalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of intravitreal injections after two years

Secondary

MeasureTime frame
Best-corrected visual acuity (BCVA), distance ETDRS and near LIX., Macular thickness (Central Retinal Thickness; CRT, in μm., Intraocular pressure (IOP) mmHg., Recurrence interval (maximum number of weeks from last injection to relapse), at first and last relapse., Durability (longest inactive interval detected, in number of weeks)., Cost efficiency: Quality-adjusted life years (QALY), cost-per-QALY is measured with the EuroQol-5 Dimension (EQ-5D) questionnaire., Vision-related quality of life (NEI VFQ-25)., Cost-benefit analysis: The incremental cost-effectiveness ratio (ICER).

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026