A Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD)

NCT06699914 | Completed

• 1 other identifier: CRTH258A1001
• Study Type: observational
• Target: 438
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective, observational, single-arm, non-randomized cohort study of ocular treatment in nAMD patients in Japan who had records of at least 12 months of follow-up after their first brolucizumab intravitreal injection. Patients who had records of at least 12 months of visits after the first brolucizumab injection (index date) were identified during the index period and were recruited during the data collection/recruitment period.

Conditions

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Absence of Intra-retinal Fluid (IRF) and Absence of Subretinal Fluid (SRF) at Month 12

  Month 12

• Number of Patients With Absence of IRF and Absence of SRF at Month 3, 6, 9, and 18

  Month 3, 6, 9, and 18

Secondary Outcomes (55)

• Demographic: Age

  Baseline

• Demographic: Number of Patients per Age Category

  Baseline

• Demographic: Gender

  Baseline

• Number of Patients per Clinical Characteristic

  Baseline

• Clinical Characteristic: Time Between Diagnosis and First Brolucizumab Injection

  Baseline

Study Arms (2)

Naive Group

Japanese patients diagnosed with nAMD who did not receive any anti-vascular endothelial growth factor (VEGF) injections during the 12 months before receiving brolucizumab.

Pre-treated Group

Japanese patients diagnosed with nAMD who received at least one injection of another anti-VEGF treatment during the 12 months before receiving brolucizumab.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Diagnosis of nAMD.
• Patients 50 years of age or older at index.
• Received first injection of brolucizumab during the index period.
• Gave signed or verbal informed consent.

You may not qualify if:

• Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and who had diagnoses of diabetes-related macular degeneration within 6 Months prior to the index date.
• Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date.
• Patients who had any contraindication and were not eligible for treatment with brolucizumab according to the label.
• Patients who were treated with more than 3 types of anti-vascular endothelial growth factor (anti-VEGF) before the index date (5th line brolucizumab patients or more).
• Patients participating in parallel in an interventional clinical trial.
• Patients participating in post-marketing surveillance with brolucizumab.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

• Ohnaka M, Sakurada Y, Hayashi A, Kadonosono K, Ohno H, Mori R, Matsumoto H, Nagamori I, Murata Y, Maio-Twofoot T, Karcher H, Takahashi H. Real-World Outcomes of Brolucizumab Treatment in Japanese Patients with Neovascular Age-Related Macular Degeneration: A 12-Month, Multicenter Study. Ophthalmol Ther. 2025 Jul;14(7):1551-1565. doi: 10.1007/s40123-025-01159-2. Epub 2025 May 28.

  PMID: 40434532 DERIVED

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: September 6, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (1)