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Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Primary Purpose

Neovascular Age-related Macular Degeneration (nAMD)

Status
Active
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Injection Brolucizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (nAMD) focused on measuring Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female or male, treatment naïve patient with ≥50 years of age, with neovascular age-related macular degeneration (nAMD).
  • Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.

Note: In case where both eyes are affected, data of only one eye ['study eye'] will be recorded. Selection of the eye to be considered for the purpose of the study [referred to as 'study eye'] will be as per the Investigator's discretion.

Exclusion Criteria:

  • Patients fulfilling any of the following criteria are not eligible for this study:
  • Patient having other eye diseases that could compromise the VA.
  • Patient with existing or suspected ocular or periocular infection in the study eye.
  • Patient with an existing intraocular inflammation (IOI).
  • Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
  • Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study.
  • Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brolucizumab

Arm Description

Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment. Its Intravitreal injections. Brolucizumab 6 mg will be administered by IVT injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients will receive loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) will be performed based on BCVA and OCT to assess whether the patient will require q8w or q12w dosing.

Outcomes

Primary Outcome Measures

Incidence and characteristics of treatment-emergent adverse events during the 56 weeks of treatment with brolucizumab.
To evaluate ocular & non-ocular safety of intravitreal brolucizumab in real-world patients with nAMD.

Secondary Outcome Measures

Mean change in BCVA from baseline to week 16 and week 56 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA) from baseline to Week 56.
Percentage (%) of patient eyes with gain in BCVA of 15/10/5 ETDRS letters or more from baseline to week 16 and week 56.
To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA) from baseline to Week 56.
Percentage (%) of patient eyes with loss in BCVA of 15/10/5 ETDRS letters or more from baseline to week 16 and week 56.
To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA) from baseline to Week 56.
Number of anti-VEGF injections, during the 56 weeks of treatment with brolucizumab.
Characterize the number of anti-VEGF injections during the 56 weeks of treatment with brolucizumab.
Number of Non-injection visits during the 56 weeks of treatment with brolucizumab.
Characterize number of non-injection visits during the 56 weeks of treatment with brolucizumab.
Total number of visits during the 56 weeks of treatment with brolucizumab.
Characterize the total number of visits during the 56 weeks of treatment with brolucizumab.
Percentage (%) of patient eyes with at least one duration of interval between injections ≥ 8 weeks but <12 weeks.
Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w during the 56 weeks of treatment with brolucizumab.
Percentage (%) of patient eyes with at least one duration of interval between injections ≥ 12 weeks.
Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w during the 56 weeks of treatment with brolucizumab.
Absence of intra-retinal fluid from baseline to week 16 and week 56.
Estimate effect of brolucizumab on fluid (increased/reduced/unchanged) from baseline to week 16 and week 56 based on Optical Coherence Tomography Image Analysis.
Absence of sub-retinal fluid from baseline to week 16 and week 56.
Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56.
Estimate CST change from baseline to week 16 and at week 56.
Estimate effect of brolucizumab on central subfield thickness (CST) from baseline to week 16 and week 56 as measured by Optical Coherence Tomography (in µm)

Full Information

First Posted
February 16, 2022
Last Updated
July 10, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05269966
Brief Title
Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Official Title
A Real-world, Prospective, Multi-center, Open-label, Phase IV Clinical Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) patients that more closely resemble the real-world population intended to be treated with brolucizumab. This study is being conducted as part of the post-marketing regulatory commitment to the Indian Health authority.
Detailed Description
This is a prospective, multi-center, open-label, interventional phase IV clinical study. The study treatment i.e. brolucizumab will be prescribed in terms of the marketing authorization; the assignment of the patient to the therapy will be decided within the current practice and the medical indication, and will clearly be separated from the decision to include the patient in the study. All patients with nAMD who are planned to be treated with brolucizumab and have provided informed consent may be enrolled in this study. The treatment period for each patient will be 56 weeks after the start of brolucizumab treatment. Study visits will be scheduled at week 4, week 8, week 16, and thereafter at intervals of 8 weeks or 12 weeks after disease activity assessment at week 16. If the investigators require more frequent follow-up visits, it can be done according to their discretion and clinical judgment. Any patient who suffers from intra-ocular inflammation (IOI) during the study period would not be re-challenged with brolucizumab. Data originating from assessments and evaluations performed will be collected from the patient's medical records at Baseline (BL), i.e. start of brolucizumab treatment, week 4, week 8, week 16, week 20, week 24, week 32, week 40, week 44, week 48 and at week 56.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration (nAMD)
Keywords
Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brolucizumab
Arm Type
Experimental
Arm Description
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment. Its Intravitreal injections. Brolucizumab 6 mg will be administered by IVT injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients will receive loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) will be performed based on BCVA and OCT to assess whether the patient will require q8w or q12w dosing.
Intervention Type
Biological
Intervention Name(s)
Injection Brolucizumab
Other Intervention Name(s)
Trade Names: Pagenax, Beovu, Vsiqq
Intervention Description
Single-chain antibody fragment (scFv) Brolucizumab 6 mg will be administered by IVT injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients will receive loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) will be performed based on BCVA and OCT to assess whether the patient will require q8w or q12w dosing.
Primary Outcome Measure Information:
Title
Incidence and characteristics of treatment-emergent adverse events during the 56 weeks of treatment with brolucizumab.
Description
To evaluate ocular & non-ocular safety of intravitreal brolucizumab in real-world patients with nAMD.
Time Frame
Week 56
Secondary Outcome Measure Information:
Title
Mean change in BCVA from baseline to week 16 and week 56 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
Description
To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA) from baseline to Week 56.
Time Frame
Week 56
Title
Percentage (%) of patient eyes with gain in BCVA of 15/10/5 ETDRS letters or more from baseline to week 16 and week 56.
Description
To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA) from baseline to Week 56.
Time Frame
Week 56
Title
Percentage (%) of patient eyes with loss in BCVA of 15/10/5 ETDRS letters or more from baseline to week 16 and week 56.
Description
To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA) from baseline to Week 56.
Time Frame
Week 56
Title
Number of anti-VEGF injections, during the 56 weeks of treatment with brolucizumab.
Description
Characterize the number of anti-VEGF injections during the 56 weeks of treatment with brolucizumab.
Time Frame
Week 56
Title
Number of Non-injection visits during the 56 weeks of treatment with brolucizumab.
Description
Characterize number of non-injection visits during the 56 weeks of treatment with brolucizumab.
Time Frame
56 Weeks
Title
Total number of visits during the 56 weeks of treatment with brolucizumab.
Description
Characterize the total number of visits during the 56 weeks of treatment with brolucizumab.
Time Frame
56 Weeks
Title
Percentage (%) of patient eyes with at least one duration of interval between injections ≥ 8 weeks but <12 weeks.
Description
Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w during the 56 weeks of treatment with brolucizumab.
Time Frame
Week 56
Title
Percentage (%) of patient eyes with at least one duration of interval between injections ≥ 12 weeks.
Description
Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w during the 56 weeks of treatment with brolucizumab.
Time Frame
Week 56
Title
Absence of intra-retinal fluid from baseline to week 16 and week 56.
Description
Estimate effect of brolucizumab on fluid (increased/reduced/unchanged) from baseline to week 16 and week 56 based on Optical Coherence Tomography Image Analysis.
Time Frame
Week 56
Title
Absence of sub-retinal fluid from baseline to week 16 and week 56.
Description
Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56.
Time Frame
Week 56
Title
Estimate CST change from baseline to week 16 and at week 56.
Description
Estimate effect of brolucizumab on central subfield thickness (CST) from baseline to week 16 and week 56 as measured by Optical Coherence Tomography (in µm)
Time Frame
Week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female or male, treatment naïve patient with ≥50 years of age, with neovascular age-related macular degeneration (nAMD). Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study. Note: In case where both eyes are affected, data of only one eye ['study eye'] will be recorded. Selection of the eye to be considered for the purpose of the study [referred to as 'study eye'] will be as per the Investigator's discretion. Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for this study: Patient having other eye diseases that could compromise the VA. Patient with existing or suspected ocular or periocular infection in the study eye. Patient with an existing intraocular inflammation (IOI). Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment. Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study. Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Asarwa
State/Province
Ahmedabad
ZIP/Postal Code
380016
Country
India
Facility Name
Novartis Investigative Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 010
Country
India
Facility Name
Novartis Investigative Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600018
Country
India
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Facility Name
Novartis Investigative Site
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221010
Country
India
Facility Name
Novartis Investigative Site
City
Hooghly
State/Province
West Bengal
ZIP/Postal Code
712223
Country
India
Facility Name
Novartis Investigative Site
City
Kolkatta
State/Province
West Bengal
ZIP/Postal Code
700 073
Country
India
Facility Name
Novartis Investigative Site
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Novartis Investigative Site
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
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Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

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