The Sahlgrenska Anti-VEGF Study

NCT04101877 | Active Not Recruiting Phase 2

• 2 other identifiers: SAHLVE2018-004438-14
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Number of injections

  Number of intravitreal injections

  Two years

Secondary Outcomes (9)

• Best-corrected visual acuity (BCVA), distance

  Two years

• Best-corrected visual acuity (BCVA), near

  Two years

• Macular thickness (Central Retinal Thickness; CRT)

  Two years

• Intraocular pressure (IOP)

  Two years

• Recurrence interval

  Two years

Study Arms (2)

Avastin

EXPERIMENTAL

bevacizumab 25 mg/ml, intravitreal administration, 0.05 ml (1.25 mg)

Drug: Bevacizumab Injection

Eylea

ACTIVE COMPARATOR

aflibercept 40 mg/ml, intravitreal administration, 0.05 ml (2 mg)

Drug: Aflibercept Injection

Interventions

Bevacizumab Injection DRUG

25 mg/ml

Also known as: Avastin

Avastin

Aflibercept Injection DRUG

40 mg/ml

Also known as: Eylea

Eylea

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology

Mölndal, Sweden

Location

MeSH Terms

Interventions

Bevacizumab; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Madeleine Zetterberg, MD, PhD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective, controlled, randomized, double-blind

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 24, 2019
• Study Start: September 3, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)