Age-Related Macular Degeneration (ARMD) Clinical Trials

Find Age-Related Macular Degeneration (ARMD) Clinical Trials Near You

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

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
Grantham Hospital
Hong Kong
Time Frame
Start Date: 2022-07-25
Completion Date: 2023-08-30
Participants
Target number of participants: 30
Treatments
Experimental: Brolucizumab
new drug (brolocizumab) and novel treatment protocol
Active_comparator: Aflibercept
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
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov

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