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The Sahlgrenska Anti-VEGF Study (SAHLVE)

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Bevacizumab Injection
Aflibercept Injection
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Vastra Gotaland Region, Sahlgrenska University Hospital, Department of OphthalmologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Avastin

Eylea

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of injections
Number of intravitreal injections

Secondary Outcome Measures

Best-corrected visual acuity (BCVA), distance
ETDRS
Best-corrected visual acuity (BCVA), near
LIX
Macular thickness (Central Retinal Thickness; CRT)
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 (number of weeks).
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.
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.
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.

Full Information

First Posted
September 13, 2019
Last Updated
June 8, 2023
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT04101877
Brief Title
The Sahlgrenska Anti-VEGF Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, controlled, randomized, double-blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
402 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avastin
Arm Type
Experimental
Arm Description
bevacizumab 25 mg/ml, intravitreal administration, 0.05 ml (1.25 mg)
Arm Title
Eylea
Arm Type
Active Comparator
Arm Description
aflibercept 40 mg/ml, intravitreal administration, 0.05 ml (2 mg)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab Injection
Other Intervention Name(s)
Avastin
Intervention Description
25 mg/ml
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection
Other Intervention Name(s)
Eylea
Intervention Description
40 mg/ml
Primary Outcome Measure Information:
Title
Number of injections
Description
Number of intravitreal injections
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity (BCVA), distance
Description
ETDRS
Time Frame
Two years
Title
Best-corrected visual acuity (BCVA), near
Description
LIX
Time Frame
Two years
Title
Macular thickness (Central Retinal Thickness; CRT)
Description
μm
Time Frame
Two years
Title
Intraocular pressure (IOP)
Description
mmHg
Time Frame
Two years
Title
Recurrence interval
Description
Maximum number of weeks from last injection to relapse, at first and last relapse.
Time Frame
Two years
Title
Durability
Description
Longest inactive interval detected (number of weeks).
Time Frame
Two years
Title
Cost efficiency
Description
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.
Time Frame
Two years
Title
Vision-related quality of life
Description
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.
Time Frame
Two years
Title
Cost-benefit
Description
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.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madeleine Zetteberg, MD, PhD
Phone
+46 (0)31-3433255
Email
madeleine.zetterberg@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeleine Zetterberg, MD, PhD
Organizational Affiliation
Vastra Gotaland Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology
City
Mölndal
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeleine Zetterberg, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared, however, the results (group-level) will be available within one year of study completion.

Learn more about this trial

The Sahlgrenska Anti-VEGF Study

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