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NCT Number: NCT04932980

Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Wet Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berner Augenklinik

Bern, 3007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

administration of anti-VEGF Aflibercept (Eylea)

Brolucizumab

Drug

administration of anti-VEGF Brolucizumab (Beovu)

early treat and extend (T&E)

Procedure

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

Primary outcomes

  1. Number of injections given until week 52

    Time frame: 52 weeks

    number injections received by patient

Secondary outcomes

  1. Injections until week 104

    Time frame: 104 weeks

    number injections received by patient

  2. Number of treatment failures

    Time frame: 52 weeks

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

  3. Number of treatment failures

    Time frame: 104 weeks

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

  4. Time until drying of retina

    Time frame: 52 weeks

    mean interval until absence of intra- and subretinal fluid

  5. Time until drying of retina

    Time frame: 104 weeks

    mean interval until absence of intra- and subretinal fluid

  6. portion of eyes without disease activity

    Time frame: 52 weeks

    % patients with absence of intra- and subretinal fluid

  7. portion of eyes without disease activity

    Time frame: 104 weeks

    % patients with absence of intra- and subretinal fluid

  8. eyes under treatment intervals of ≥12 weeks

    Time frame: 52 weeks

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

  9. eyes under treatment intervals of ≥12 weeks

    Time frame: 104 weeks

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

  10. Change in visual acuity

    Time frame: 52 weeks

    change of VA in logRAD from baseline to week 52

  11. Change in visual acuity

    Time frame: 104 weeks

    change of VA in logRAD from baseline to week 104

  12. Change in central subfield thickness (CST)

    Time frame: 52 weeks

    change from baseline to week 52

  13. Change in central subfield thickness (CST)

    Time frame: 104 weeks

    change from baseline to week 104

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

    Time frame: 52 weeks

    change from baseline to week 52

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

    Time frame: 104 weeks

    change from baseline to week 104

  16. Maximal treatment interval extension

    Time frame: 52 weeks

    mean treatment interval extension

  17. Maximal treatment interval extension

    Time frame: 104 weeks

    mean treatment interval extension

Sponsors and collaborators

Lead sponsor

Berner Augenklinik

Other

Collaborators

  • medignition AG

Registry information

Official study title

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

Acronym: SPARROW

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jun 21, 2021
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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