A Phase 4 interventional study of Brolucizumab and Aflibercept in Age-Related Macular Degeneration, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by The University of Hong Kong · Phase 4, Interventional, and Treatment
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
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.
1,490 studies on the registry are indexed under Macular Degeneration; 208 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 993 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Ocular criteria:
Systemic criteria:
new drug (brolocizumab) and novel treatment protocol
Drug: Brolucizumab
aflibercept and continuing on the traditional T\&E protocol. There will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolocizumab
Drug: Aflibercept
Intravitreal injection
Also known as: Beovu
Intravitreal injection
Also known as: Eylea
Central Macular thickness
Measurement of the change in macular thickness (um)
Time frame: 1 year
Visual acuity
Change in best corrected visual acuity (BCVA), LogMAR
Time frame: 1 year
Treatment interval
Change in the duration of the treatment interval between each injection (weeks)
Time frame: 1 year
Complications
Relating to the drug (eg. Inflammation), relating to the procedure (glaucoma, cataract, retinal detachment, haemorrhage etc)
Time frame: 1 year
Optical Coherence Tomography features
Changes and presence of OCT features during every follow-up visit
Time frame: 1 year
Plan to share: Yes — By direct contact to the corresponding author or principle investigator
Supporting information: Study protocol, Clinical study report
Time frame: 5 years after study ends
Access criteria: Case by case
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brolucizumab