Clinical trial NCT05710471: Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E
Official title: Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With a Novel Treat and Extend Protocol - a Randomized Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel interventional arms with option of rescue treatment
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Central Macular thickness
timeFrame: 1 year
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 year
measure: Treatment interval
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
measure: Optical Coherence Tomography features
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Grantham Hospital
Study officials:
References:
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