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Completed

NCT Number: NCT05710471

Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E

The investigator propose to conduct a randomized clinical trial, investigating the safety and efficacy of brolucizumab for treatment of nAMD patients with CNV, and plans to specifically target those who are not responding to standard Treat and Extend (T&E) treatment. A randomised omized study will be conducted with 2 arms, one with the new drug (brolocizumab) and novel treatment protocol versus a second arm using the current gold standard of aflibercept and the T&E protocol

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Grantham Hospital

Hong Kong

About this study

In addition, there will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolucizumab. The primary outcome is the change in central macular thickness, since we expect the new treatment to be effective in reducing intraretinal and subretinal fluids, which in effect are indicators of disease activity. In addition, investigator will look at the improvement of visual acuity, the reduction of treatment intervals, total number of injections over 1 year, recurrence rate and safety profiles of both drugs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 50 and above
  • Diagnosis of exudative age-related macular degeneration (subfoveal CNV) as shown on optical coherence tomography (OCT) - presence of intraretinal fluid, subretinal fluid or subretinal hyperreflective material and/or FFA (leakage classified as subfoveal or as juxtafoveal or extrafoveal)
  • Actively treated with aflibercept and given 3 monthly loading doses followed by treat and extend
  • Maximal interval period is less than or equal to 8 weekly injections
  • Patients must understand and sign the ethics board approved consent form

Exclusion criteria

  • Ocular criteria:
  • Co-existing retinal and/or macular disease (DME, RVO, high myopia of 8 diopters or more, retinal detachment, macular hole stage 2 or above, significant vitreomacular traction or epiretinal membrane, etc.)
  • Co-existing ocular disease (glaucoma, uveitis etc.)
  • History of uveitis or intraocular inflammation, scleritis, or episcleritis
  • History of corneal transplant, pars planar vitrectomy or aphakia
  • History of therapeutic radiation to the region of the study eye
  • Media opacity obstructing investigation or assessment (cataract, corneal scar, vitreous hemorrhage)
  • Treat and extend period beyond 8 weeks
  • Any intravitreal injection of steroid within 3 months before randomization
  • Systemic criteria:
  • Poorly controlled systemic disease including hypertension and diabetes
  • Any acute coronary event or stroke within 6 months before randomization
  • Malignancy within 5 years
  • Systemic anti-VEGF treatment
  • Allergy or sensitivity to investigational product, including fluoresceine dye, anesthetics, aflibercept or brolucizumab

Treatment and study plan

Brolucizumab

Drug

Intravitreal injection

Other names: Beovu

aflibercept

Drug

Intravitreal injection

Other names: Eylea

Primary outcomes

  1. Central Macular thickness

    Time frame: 1 year

    Measurement of the change in macular thickness (um)

Secondary outcomes

  1. Visual acuity

    Time frame: 1 year

    Change in best corrected visual acuity (BCVA), LogMAR

  2. Treatment interval

    Time frame: 1 year

    Change in the duration of the treatment interval between each injection (weeks)

  3. Complications

    Time frame: 1 year

    Relating to the drug (eg. Inflammation), relating to the procedure (glaucoma, cataract, retinal detachment, haemorrhage etc)

  4. Optical Coherence Tomography features

    Time frame: 1 year

    Changes and presence of OCT features during every follow-up visit

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With a Novel Treat and Extend Protocol - a Randomized Controlled Prospective Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2023
Registry last updated
May 8, 2024

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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