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Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD (SPARROW)

Primary Purpose

Wet Age-related Macular Degeneration

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Aflibercept
Brolucizumab
early treat and extend (T&E)
Sponsored by
Berner Augenklinik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Age-related Macular Degeneration focused on measuring wAMD, Treat & Extend, Aflibercept, Brolucizumab, Loading-phase

Eligibility Criteria

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

Inclusion Criteria:

  • Active MNV secondary to nAMD, going along with clinically significant vision loss
  • Patients aged 50 years or older of all sexes
  • Presence of IRF and/or SRF and/or subretinal hyperreflective material affecting the central subfield of the study eye on OCT
  • signed informed consent for this study prior to the screening visit
  • If possible: availability of a smartphone and willingness to perform self-testing with the Alleye app (soft criteria)

Exclusion Criteria:

  • Any other cause of macular oedema
  • Structural damage to the macula precluding a visual potential
  • Optical media opacities not allowing an accurate performance of the protocol examinations
  • Any intraocular surgery within three months prior to inclusion and history of any vitreoretinal surgery
  • Advanced diabetic retinopathy potentially requiring any treatment within six months following inclusion or history of vitreal haemorrhage
  • Presence of vitreoretinal traction or tractive epiretinal membrane affecting the fovea
  • History of IVT with anti-VEGF or corticosteroids at any time in the study eye
  • Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
  • Significantly worse functional prognosis in the other eye or only eye
  • Women of childbearing potential not willing to use an effective method of contraception during treatment and until at least 3 months after the last treatment
  • Pregnant or lactating women
  • Any systemic auto-inflammatory and auto-immune disease requiring treatment
  • Treatment with high-dose corticosteroids (Prednisone equivalent >5mg/day), immunosuppressive or immunomodulatory or anti-proliferative agents for any reason
  • Inability or contraindications to undergo the investigated intervention

Sites / Locations

  • Berner Augenklinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aflibercept ® rapid treatment extension (T&E)

Brolucizumab ® rapid treatment extension (T&E)

Arm Description

Early treat and extend (T&E) with Aflibercept ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.

Early treat and extend (T&E) with Brolucizumab ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.

Outcomes

Primary Outcome Measures

Number of injections given until week 52
number injections received by patient

Secondary Outcome Measures

Injections until week 104
number injections received by patient
Number of treatment failures
number with treatment demand of less than 6 weeks at any time point
Number of treatment failures
number with treatment demand of less than 6 weeks at any time point
Time until drying of retina
mean interval until absence of intra- and subretinal fluid
Time until drying of retina
mean interval until absence of intra- and subretinal fluid
portion of eyes without disease activity
% patients with absence of intra- and subretinal fluid
portion of eyes without disease activity
% patients with absence of intra- and subretinal fluid
eyes under treatment intervals of ≥12 weeks
portion of eyes with stable disease under treatment intervals of ≥12 weeks
eyes under treatment intervals of ≥12 weeks
portion of eyes with stable disease under treatment intervals of ≥12 weeks
Change in visual acuity
change of VA in logRAD from baseline to week 52
Change in visual acuity
change of VA in logRAD from baseline to week 104
Change in central subfield thickness (CST)
change from baseline to week 52
Change in central subfield thickness (CST)
change from baseline to week 104
Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters
change from baseline to week 52
Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters
change from baseline to week 104
Maximal treatment interval extension
mean treatment interval extension
Maximal treatment interval extension
mean treatment interval extension

Full Information

First Posted
June 6, 2021
Last Updated
July 26, 2023
Sponsor
Berner Augenklinik
Collaborators
medignition AG
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1. Study Identification

Unique Protocol Identification Number
NCT04932980
Brief Title
Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD
Acronym
SPARROW
Official Title
Study Comparing Early Extension of Aflibercept and Brolucizumab in Wet AMD (SPARROW)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Berner Augenklinik
Collaborators
medignition AG

4. Oversight

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

5. Study Description

Brief Summary
The currently widely established and preferred protocol for the treatment of wet age-related macular degeneration includes a loading phase of three monthly injections without interim adaptation or treatment according to disease activity, thereafter following a T&E strategy with treatment adaptation in increments of 2-4 weeks according to disease activity. Based on pharmacological considerations regarding the vitreal half-life of the drugs, the aim of this prospective explorative study is to test whether an early extension of treatment intervals without a loading phase is an option without compromising functional outcomes. Based on a superiority of Afl compared to Ran with regard to achieving a dry retina after one year and based on studies, but in the absence of real-life experience with Bro, it seems of interest to test how far Afl and Bro are comparable in terms of their potential to extend the treatment intervals over 12 months, the time to dryness of the retina, and number of injections. Also, it is of high clinical relevance to demonstrate efficacy with longer initial treatment intervals compared to the current possibly over-treating loading-phase with three four-weekly injections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Age-related Macular Degeneration
Keywords
wAMD, Treat & Extend, Aflibercept, Brolucizumab, Loading-phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two-armed, randomized, double-blind
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept ® rapid treatment extension (T&E)
Arm Type
Active Comparator
Arm Description
Early treat and extend (T&E) with Aflibercept ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
Arm Title
Brolucizumab ® rapid treatment extension (T&E)
Arm Type
Active Comparator
Arm Description
Early treat and extend (T&E) with Brolucizumab ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
administration of anti-VEGF Aflibercept (Eylea)
Intervention Type
Drug
Intervention Name(s)
Brolucizumab
Intervention Description
administration of anti-VEGF Brolucizumab (Beovu)
Intervention Type
Procedure
Intervention Name(s)
early treat and extend (T&E)
Intervention Description
extension of treatment intervals (T&E) from the beginning of treatment
Primary Outcome Measure Information:
Title
Number of injections given until week 52
Description
number injections received by patient
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Injections until week 104
Description
number injections received by patient
Time Frame
104 weeks
Title
Number of treatment failures
Description
number with treatment demand of less than 6 weeks at any time point
Time Frame
52 weeks
Title
Number of treatment failures
Description
number with treatment demand of less than 6 weeks at any time point
Time Frame
104 weeks
Title
Time until drying of retina
Description
mean interval until absence of intra- and subretinal fluid
Time Frame
52 weeks
Title
Time until drying of retina
Description
mean interval until absence of intra- and subretinal fluid
Time Frame
104 weeks
Title
portion of eyes without disease activity
Description
% patients with absence of intra- and subretinal fluid
Time Frame
52 weeks
Title
portion of eyes without disease activity
Description
% patients with absence of intra- and subretinal fluid
Time Frame
104 weeks
Title
eyes under treatment intervals of ≥12 weeks
Description
portion of eyes with stable disease under treatment intervals of ≥12 weeks
Time Frame
52 weeks
Title
eyes under treatment intervals of ≥12 weeks
Description
portion of eyes with stable disease under treatment intervals of ≥12 weeks
Time Frame
104 weeks
Title
Change in visual acuity
Description
change of VA in logRAD from baseline to week 52
Time Frame
52 weeks
Title
Change in visual acuity
Description
change of VA in logRAD from baseline to week 104
Time Frame
104 weeks
Title
Change in central subfield thickness (CST)
Description
change from baseline to week 52
Time Frame
52 weeks
Title
Change in central subfield thickness (CST)
Description
change from baseline to week 104
Time Frame
104 weeks
Title
Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters
Description
change from baseline to week 52
Time Frame
52 weeks
Title
Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters
Description
change from baseline to week 104
Time Frame
104 weeks
Title
Maximal treatment interval extension
Description
mean treatment interval extension
Time Frame
52 weeks
Title
Maximal treatment interval extension
Description
mean treatment interval extension
Time Frame
104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active MNV secondary to nAMD, going along with clinically significant vision loss Patients aged 50 years or older of all sexes Presence of IRF and/or SRF and/or subretinal hyperreflective material affecting the central subfield of the study eye on OCT signed informed consent for this study prior to the screening visit If possible: availability of a smartphone and willingness to perform self-testing with the Alleye app (soft criteria) Exclusion Criteria: Any other cause of macular oedema Structural damage to the macula precluding a visual potential Optical media opacities not allowing an accurate performance of the protocol examinations Any intraocular surgery within three months prior to inclusion and history of any vitreoretinal surgery Advanced diabetic retinopathy potentially requiring any treatment within six months following inclusion or history of vitreal haemorrhage Presence of vitreoretinal traction or tractive epiretinal membrane affecting the fovea History of IVT with anti-VEGF or corticosteroids at any time in the study eye Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. Significantly worse functional prognosis in the other eye or only eye Women of childbearing potential not willing to use an effective method of contraception during treatment and until at least 3 months after the last treatment Pregnant or lactating women Any systemic auto-inflammatory and auto-immune disease requiring treatment Treatment with high-dose corticosteroids (Prednisone equivalent >5mg/day), immunosuppressive or immunomodulatory or anti-proliferative agents for any reason Inability or contraindications to undergo the investigated intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christof Hänsli, Dr. med.
Organizational Affiliation
Berner Augenklinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berner Augenklinik
City
Bern
ZIP/Postal Code
3007
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24879948
Citation
Fauser S, Schwabecker V, Muether PS. Suppression of intraocular vascular endothelial growth factor during aflibercept treatment of age-related macular degeneration. Am J Ophthalmol. 2014 Sep;158(3):532-6. doi: 10.1016/j.ajo.2014.05.025. Epub 2014 May 28.
Results Reference
background
PubMed Identifier
33528645
Citation
Garweg JG, Gerhardt C. Disease stability and extended dosing under anti-VEGF treatment of exudative age-related macular degeneration (AMD) - a meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2021 Aug;259(8):2181-2192. doi: 10.1007/s00417-020-05048-1. Epub 2021 Feb 2.
Results Reference
background

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Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

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