Comparing two treatments for wet age-related macular degeneration
The Sahlgrenska Anti-VEGF (SAHLVE) Study - a Prospective Randomized Double-blind Comparison of Bevacizumab and Aflibercept in Patients With Neovascular Age-related Macular Degeneration
This study is testing whether two different eye treatments for wet age-related macular degeneration, Avastin and Eylea, work better in the long run and if one requires fewer injections than the other.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 402 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Mölndal) |
| Trial ID | NCT04101877 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two different treatments for neovascular age-related macular degeneration (AMD): intravitreal injections of bevacizumab (Avastin) and aflibercept (Eylea). It aims to determine if patients receiving bevacizumab after two years require more injections while maintaining therapy response compared to those treated with aflibercept. Additionally, the study evaluates differences in visual acuity, macular thickness, recurrence intervals, treatment durability, cost efficiency, and quality of life related to vision. The findings could provide insights into the most effective long-term treatment options for AMD.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 and older diagnosed with neovascular age-related macular degeneration.
Not a fit: Patients with other eye diseases affecting visual acuity, those who have previously received treatment for AMD, or those with diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the more effective treatment option for patients with wet age-related macular degeneration, potentially improving their vision and quality of life.
How similar studies have performed: Other studies have shown varying success with similar treatment comparisons for AMD, but this specific approach is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 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).
Where this trial is running
Mölndal
- Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology — Mölndal, Sweden (Recruiting)
Study contacts
- Principal investigator: Madeleine Zetterberg, MD, PhD — Vastra Gotaland Region
- Study coordinator: Madeleine Zetteberg, MD, PhD
- Email: madeleine.zetterberg@vgregion.se
- Phone: +46 (0)31-3433255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.