The Sahlgrenska Anti-VEGF Study

Sponsor
Vastra Gotaland Region
Study ID
NCT04101877
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 3, 2020
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
402 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Avastin
    bevacizumab 25 mg/ml, intravitreal administration, 0.05 ml (1.25 mg)
  • Active Comparator: Eylea
    aflibercept 40 mg/ml, intravitreal administration, 0.05 ml (2 mg)

Primary Outcome Measure

Number of injections [ Time Frame: Two years ]

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