The Sahlgrenska Anti-VEGF Study

Neovascular Age-related Macular Degeneration Clinical Trial

— SAHLVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04101877
• Other study ID #: SAHLVE
• Secondary ID: 2018-004438-14
• Status: Recruiting
• Phase: Phase 2
• Start date: September 3, 2020
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Vastra Gotaland Region
• Contact: Madeleine Zetteberg, MD, PhD
• Phone: +46 (0)31-3433255
• Email: madeleine.zetterberg[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 402
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Bevacizumab Injection
25 mg/ml
• Aflibercept Injection
40 mg/ml

Locations

Country	Name	City	State
Sweden	Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology	Mölndal

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of injections	Number of intravitreal injections	Two years
Secondary	Best-corrected visual acuity (BCVA), distance	ETDRS	Two years
Secondary	Best-corrected visual acuity (BCVA), near	LIX	Two years
Secondary	Macular thickness (Central Retinal Thickness; CRT)	µm	Two years
Secondary	Intraocular pressure (IOP)	mmHg	Two years
Secondary	Recurrence interval	Maximum number of weeks from last injection to relapse, at first and last relapse.	Two years
Secondary	Durability	Longest inactive interval detected (number of weeks).	Two years
Secondary	Cost efficiency	Quality-adjusted life years (QALY), cost-per-QALY is measured with the EuroQol-5 Dimension (EQ-5D) questionnaire.; EQ-5D consists of five subscales: mobility, self-care, usual activities, discomfort/pain and anxiety/depression. The subscales measure different aspects of health and well-being where the subject is asked to rank each subscale from 1 (no problems) to 3 (major problems). These answers are converted to a score between 0 (=death) to 1 (=full health). The subscales are converted to a weighted mean which ranges from 0 (death) to 1 (full health). Negative values may exists for conditions worse than death. The weighting differs between geographic areas; for Sweden, the UK weighting scale is used.	Two years
Secondary	Vision-related quality of life	National Eye Institute Visual Functioning Questionnaire -25 (NEI VFQ-25) questionnaire is based on 25 questions (items) where the subject is asked questions on visual function, daily activities and social consequences of visual function. The questions have answers on a 5- or 6-grade scale which are converted to a scale from 0 (no function/worst consequence) to 100 (no problems). The 25 items are clustered into 12 subscales. Items within each subscale are averaged to create the subscale scores according to the NEI VFQ-25 scoring algorithm. In addition, a composite score for all 12 subscales are created as an average of these. Minimum score is 0 and maximum score is 100 for each item, subscale and the composite score.	Two years
Secondary	Cost-benefit	The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It represents the average incremental cost associated with 1 additional unit of the measure of effect and is given in Euro.	Two years