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

Novartis

Status and phase: Completed; Phase 4

Conditions: Neovascular Age-related Macular Degeneration (nAMD)

Treatments: Biological: Injection Brolucizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05269966

CRTH258AIN01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 105 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Brolucizumab

Experimental group

Description:

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.

Treatment:

Biological: Injection Brolucizumab