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

April 16, 2024 updated by: Novartis Pharmaceuticals

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)

The purpose of this study was 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 was conducted as part of the post-marketing regulatory commitment to the Indian Health authority.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was a prospective, multi-center, open-label, interventional phase IV clinical study.

The study treatment, i.e., brolucizumab was prescribed in terms of the marketing authorization; the assignment of the patient to the therapy was decided within the current practice and the medical indication. It was clearly separated from the decision to include the patient in the study.

All patients with Neovascular Age-related Macular Degeneration (nAMD) who were planned to be treated with brolucizumab and had provided informed consent were enrolled in the study. A total of 12 sites in India were evaluated for the study conduct. This is to note that site #03 was not selected, and site #07 was not initiated, and patients were enrolled in the study only from 10 sites.

The treatment period for each patient was 56 weeks after the start of brolucizumab treatment.

Study visits were 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 required more frequent follow-up visits, it was done according to their discretion and clinical judgment. Any patient who suffered from IOI during the study period was not re-challenged with brolucizumab.

The study population consisted of adult male and female outpatients aged 50 years and above, diagnosed with nAMD for whom the treating the physician (Investigator) had prescribed treatment with brolucizumab 6 mg injection in adherence with the local Summary of Product Characteristics (SmPC) or Prescribing Information (PI).

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Novartis Investigative Site
      • New Delhi, India, 110029
        • Novartis Investigative Site
    • Ahmedabad
      • Asarwa, Ahmedabad, India, 380016
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 010
        • Novartis Investigative Site
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600018
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Novartis Investigative Site
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221010
        • Novartis Investigative Site
    • West Bengal
      • Hooghly, West Bengal, India, 712223
        • Novartis Investigative Site
      • Kolkatta, West Bengal, India, 700 073
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brolucizumab

Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.

Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients received 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) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
Biological: Injection Brolucizumab

Single-chain antibody fragment (scFv)

Brolucizumab 6 mg was administered by Intravitreal (IVT) injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients received 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) were performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.

Other Names:
  • Trade Names: Pagenax, Beovu, Vsiqq

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in BCVA from baseline to week 16 and week 56 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
Week 56
Number of anti-VEGF injections, during the 56 weeks of treatment with brolucizumab.
Time Frame: Week 56
Characterize the number of anti-VEGF injections during the 56 weeks of treatment with brolucizumab.
Week 56
Number of Non-injection visits during the 56 weeks of treatment with brolucizumab.
Time Frame: 56 Weeks
Characterize number of non-injection visits during the 56 weeks of treatment with brolucizumab.
56 Weeks
Total number of visits during the 56 weeks of treatment with brolucizumab.
Time Frame: 56 Weeks
Characterize the total number of visits during the 56 weeks of treatment with brolucizumab.
56 Weeks
Percentage (%) of patient eyes with at least one duration of interval between injections ≥ 8 weeks but <12 weeks.
Time Frame: Week 56
Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w during the 56 weeks of treatment with brolucizumab.
Week 56
Percentage (%) of patient eyes with at least one duration of interval between injections ≥ 12 weeks.
Time Frame: Week 56
Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w during the 56 weeks of treatment with brolucizumab.
Week 56
Absence of intra-retinal fluid from baseline to week 16 and week 56.
Time Frame: 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.
Week 56
Absence of sub-retinal fluid from baseline to week 16 and week 56.
Time Frame: Week 56
Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56.
Week 56
Estimate CST change from baseline to week 16 and at week 56.
Time Frame: 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)
Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Actual)

August 29, 2023

Study Completion (Actual)

August 29, 2023

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRTH258AIN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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