Age-Related Macular Degeneration
Conditions
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.
Interventions
DRUGBrolucizumab
Intravitreal injection
DRUGAflibercept
Intravitreal injection
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients are randomised and masked from the treatment
Intervention model description
Parallel interventional arms with option of rescue treatment
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Macular thickness | 1 year | Measurement of the change in macular thickness (um) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 1 year | Change in best corrected visual acuity (BCVA), LogMAR |
| Treatment interval | 1 year | Change in the duration of the treatment interval between each injection (weeks) |
| Complications | 1 year | Relating to the drug (eg. Inflammation), relating to the procedure (glaucoma, cataract, retinal detachment, haemorrhage etc) |
| Optical Coherence Tomography features | 1 year | Changes and presence of OCT features during every follow-up visit |
Countries
Hong Kong
Outcome results
None listed