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

Primary Purpose

Age-Related Macular Degeneration

Status
Recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Brolucizumab
Aflibercept
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grantham HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brolucizumab

Aflibercept

Arm Description

new drug (brolocizumab) and novel treatment protocol

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

Outcomes

Primary Outcome Measures

Central Macular thickness
Measurement of the change in macular thickness (um)

Secondary Outcome Measures

Visual acuity
Change in best corrected visual acuity (BCVA), LogMAR
Treatment interval
Change in the duration of the treatment interval between each injection (weeks)
Complications
Relating to the drug (eg. Inflammation), relating to the procedure (glaucoma, cataract, retinal detachment, haemorrhage etc)
Optical Coherence Tomography features
Changes and presence of OCT features during every follow up visit (sub retinal fluid, intraretinal fluid, pigmented epithelial defect)

Full Information

First Posted
January 25, 2023
Last Updated
February 6, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05710471
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
July 25, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel interventional arms with option of rescue treatment
Masking
Participant
Masking Description
Patients are randomised and masked from the treatment
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brolucizumab
Arm Type
Experimental
Arm Description
new drug (brolocizumab) and novel treatment protocol
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Brolucizumab
Other Intervention Name(s)
Beovu
Intervention Description
Intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Intravitreal injection
Primary Outcome Measure Information:
Title
Central Macular thickness
Description
Measurement of the change in macular thickness (um)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Change in best corrected visual acuity (BCVA), LogMAR
Time Frame
1 year
Title
Treatment interval
Description
Change in the duration of the treatment interval between each injection (weeks)
Time Frame
1 year
Title
Complications
Description
Relating to the drug (eg. Inflammation), relating to the procedure (glaucoma, cataract, retinal detachment, haemorrhage etc)
Time Frame
1 year
Title
Optical Coherence Tomography features
Description
Changes and presence of OCT features during every follow up visit (sub retinal fluid, intraretinal fluid, pigmented epithelial defect)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Fung
Phone
852 39621405
Email
nfung@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ella Lee
Email
eyhlee@hku.hk
Facility Information:
Facility Name
Grantham Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ella Lee
Email
eyhlee@hku.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
By direct contact to the corresponding author or principle investigator
IPD Sharing Time Frame
5 years after study ends
IPD Sharing Access Criteria
Case by case
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Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E

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