AzTrials
AzTrials

Wet Age-related Macular DegenerationSPARROWNCT04932980

Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

A study testing Aflibercept, Brolucizumab and early treat and extend (T&E) in people with Wet Age-related Macular Degeneration, run by Berner Augenklinik at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
Aflibercept, Brolucizumab and early treat and extend (T&E)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSwitzerland
Study dates
9 May 2022to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Berner Augenklinik

    Bern, 3007

Other trials in Switzerland

About this study

Official title: Study Comparing Early Extension of Aflibercept and Brolucizumab in Wet AMD (SPARROW)

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.

Being tested
Aflibercept, Brolucizumab, early treat and extend (T&E)
Keywords
wAMD, Treat & Extend, Aflibercept, Brolucizumab, Loading-phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfliberceptDrug

    administration of anti-VEGF Aflibercept (Eylea)

  • BrolucizumabDrug

    administration of anti-VEGF Brolucizumab (Beovu)

  • early treat and extend (T&E)Procedure or surgery

    extension of treatment intervals (T\&E) from the beginning of treatment

Study groups in NCT04932980
Study groupRoleWhat they receive
Aflibercept ® rapid treatment extension (T&E)Active comparatorEarly 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.
Receives: Drug: Aflibercept; Procedure: early treat and extend (T&E)
Brolucizumab ® rapid treatment extension (T&E)Active comparatorEarly 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.
Receives: Drug: Brolucizumab; Procedure: early treat and extend (T&E)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of injections given until week 52

    number injections received by patient

    Measured: 52 weeks

Secondary outcomes (17)

  1. Injections until week 104

    number injections received by patient

    Measured: 104 weeks

  2. Number of treatment failures

    number with treatment demand of less than 6 weeks at any time point

    Measured: 52 weeks

  3. Number of treatment failures

    number with treatment demand of less than 6 weeks at any time point

    Measured: 104 weeks

  4. Time until drying of retina

    mean interval until absence of intra- and subretinal fluid

    Measured: 52 weeks

  5. Time until drying of retina

    mean interval until absence of intra- and subretinal fluid

    Measured: 104 weeks

  6. portion of eyes without disease activity

    % patients with absence of intra- and subretinal fluid

    Measured: 52 weeks

  7. portion of eyes without disease activity

    % patients with absence of intra- and subretinal fluid

    Measured: 104 weeks

  8. eyes under treatment intervals of ≥12 weeks

    portion of eyes with stable disease under treatment intervals of ≥12 weeks

    Measured: 52 weeks

  9. eyes under treatment intervals of ≥12 weeks

    portion of eyes with stable disease under treatment intervals of ≥12 weeks

    Measured: 104 weeks

  10. Change in visual acuity

    change of VA in logRAD from baseline to week 52

    Measured: 52 weeks

  11. Change in visual acuity

    change of VA in logRAD from baseline to week 104

    Measured: 104 weeks

  12. Change in central subfield thickness (CST)

    change from baseline to week 52

    Measured: 52 weeks

  13. Change in central subfield thickness (CST)

    change from baseline to week 104

    Measured: 104 weeks

  14. Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters

    change from baseline to week 52

    Measured: 52 weeks

  15. Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters

    change from baseline to week 104

    Measured: 104 weeks

  16. Maximal treatment interval extension

    mean treatment interval extension

    Measured: 52 weeks

  17. Maximal treatment interval extension

    mean treatment interval extension

    Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2021
  2. Study start9 May 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two-armed, randomized, double-blind
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04932980
Sponsor's protocol ID
SPARROW 2021-01236
Acronym
SPARROW
Status last verified
Nov 2025
First submitted
6 Jun 2021
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24879948

  • 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.

    PubMed 33528645

Questions about this trial

What is this clinical trial studying?

A study testing Aflibercept, Brolucizumab and early treat and extend (T&E) in people with Wet Age-related Macular Degeneration, run by Berner Augenklinik at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of injections given until week 52 (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04932980, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in