Effectiveness of Brolucizumab in Pre-treated Patients With nAMD in the Real-world Setting

NCT05266495 | Terminated

• 1 other identifier: CRTH258AAE01
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective and retrospective, observational, single-arm, non-randomized cohort study of ocular treatment with intravitreal injections of brolucizumab in nAMD patients. This study will be conducted prospectively and retrospectively (for patients who had their first brolucizumab injection before study start) using data collected in a standardized manner.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

nAMD; brolucizumab; NIS

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with absence of SRF and IRF

  percentage of treated patients with absence of SRF and IRF. Patients who have discontinued brolucizumab before Month 12 will be counted as not having achieved the endpoint of fluid resolution (absence of SRF and IRF), unless they reached it at the last visit while still on brolucizumab treatment before the discontinuation.

  Month 12

Secondary Outcomes (68)

• Percentage of patients ≥ 80 years old

  Baseline

• Duration of diagnosis

  Baseline

• Percentage of patients with baseline visit

  Baseline

• Percentage of patients with bilateral disease

  Baseline

• Percentage of patients with lesion type

  Baseline

Study Arms (1)

Brolucizumab

patients who received their first injection of Brolucizumab either during the active recruitment period (1 year prospective) or during the 6 months pre-start of the recruitment (6 months retrospective)

Other: Brolucizumab

Interventions

Brolucizumab OTHER

There is no treatment allocation. Patients administered brolucizumab by prescription will be enrolled.

Brolucizumab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that started brolucizumab treatment during the study recruitment period or patients that started brolucizumab treatment during the 6 months preceding the start of study recruitment

You may qualify if:

• Diagnosis of nAMD
• Patients with ≥18 years of age at index
• Receipt of at least one injection of brolucizumab (not necessarily the first one) during the index period
• Signed informed consent

You may not qualify if:

• Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
• Receipt of any anti-VEGF treatment other than brolucizumab in the study eye during the index period
• Receipt of brolucizumab in the study eye more than 6 months before the index period, i.e., brolucizumab treatment started more than 6 months before the start of the study
• Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date
• Patients who have any contraindication and are not eligible for treatment with brolucizumab as according to the label
• Patients who were treated with more than 2 types of anti-VEGF before index date (4th line brolucizumab patients or more)
• Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 12-month study participation
• Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Abu Dhabi, 112412, United Arab Emirates

Location

Related Links

• Results for CRTH258AAE01 that is getting linked from the Novartis Clinical Trials Website

MeSH Terms

Interventions

brolucizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: April 13, 2022
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: January 13, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)